Trial Outcomes & Findings for Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer (NCT NCT01896856)

Last Updated: 2020-10-06

Results Overview

Number of participants experiencing a Dose Limiting Toxicity (DLT) in each dose level. DLT is defined as any of the following study drug-related toxicities occurring during the first cycle of study drug on study: 1. grade 4 thrombocytopenia lasting \>7days 2. any grade 3-4 febrile neutropenia 3. grade 3 or higher non-hematologic toxicity unless it could be managed by supportive treatment 4. any other clinically significant adverse event which would place subjects at undue safety risk, or results in discontinuation of treatment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

118 participants

Primary outcome timeframe

28 days

Results posted on

2020-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1: Dose Level 1 Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1 Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1G Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 1: Dose Level 1G Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 2: Arm A SGI-110 + Irinotecan SGI-110 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.	Phase 2: Arm B Regorafenib or TAS-102 Subjects received either regorafenib or Lonsurf (TAS-102). Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m\^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient.
Overall Study STARTED	6	3	7	6	62	34
Overall Study COMPLETED	6	3	6	6	62	34
Overall Study NOT COMPLETED	0	0	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: Dose Level 1 Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1 Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1G Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 1: Dose Level 1G Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 2: Arm A SGI-110 + Irinotecan SGI-110 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.	Phase 2: Arm B Regorafenib or TAS-102 Subjects received either regorafenib or Lonsurf (TAS-102). Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m\^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient.
Overall Study Transportation issues / Non-compliance	0	0	1	0	0	0

Baseline Characteristics

Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: Dose Level 1 n=6 Participants Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1 n=3 Participants Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1G n=7 Participants Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 1: Dose Level 1G n=6 Participants Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 2: Arm A SGI-110 + Irinotecan n=62 Participants SGI-110 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.	Phase 2: Arm B Regorafenib or TAS-102 n=34 Participants Subjects received either regorafenib or TAS-102. Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m\^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient.	Total n=118 Participants Total of all reporting groups
Age, Continuous	54.5 years n=5 Participants	64 years n=7 Participants	52 years n=5 Participants	54.5 years n=4 Participants	55.0 years n=21 Participants	59.5 years n=10 Participants	57.0 years n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	21 Participants n=21 Participants	18 Participants n=10 Participants	49 Participants n=115 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	41 Participants n=21 Participants	16 Participants n=10 Participants	69 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	6 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	57 Participants n=21 Participants	33 Participants n=10 Participants	112 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants	4 Participants n=10 Participants	14 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	8 Participants n=10 Participants	16 Participants n=115 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	47 Participants n=21 Participants	22 Participants n=10 Participants	85 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Per protocol, Dose Limiting Toxicities were only assessed in Phase 1 subjects in order to determine the Phase 2 dose of SGI-110. 1 Patient in Dose Level -1G was taken off study for non-compliance due to transportation issues before completion of Cycle 1 and was not considered evaluable for DLT analysis.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=6 Participants SGI-110 45 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle.	Dose Level -1 n=3 Participants SGI-110 30 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle.	Dose Level -1G n=6 Participants SGI-110 30 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.	Dose Level 1G n=6 Participants SGI-110 45 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.
Number of Participants Experiencing a Dose Limiting Toxicity	1 Participants	2 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Per protocol, the progression-free survival objective was only assessed in Phase 2 subjects. 18 subjects who received Arm B treatment were eligible to "crossover" to receive Arm A treatment. These participants were not included in the number analyzed in Arm A because they were not assessed for progression free survival after Arm A treatment.

Progression Free Survival is the time (in months) from start of treatment to progression, clinical deterioration attributed to disease, or death.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=62 Participants SGI-110 45 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle.	Dose Level -1 n=34 Participants SGI-110 30 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle.	Dose Level -1G SGI-110 30 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.	Dose Level 1G SGI-110 45 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.
Progression Free Survival (PFS)	2.37 months Interval 2.2 to 3.52	2.09 months Interval 1.91 to 2.99	—	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: Per protocol, the overall survival objective was only assessed in Phase 2 subjects. 18 subjects who received Arm B treatment and were eligible to "crossover" to receive Arm A treatment were not included in the number analyzed in Arm A because they were not assessed for overall survival after receiving Arm A treatment.

Overall Survival is defined as the time (in months) between the start of treatment and death.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=62 Participants SGI-110 45 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle.	Dose Level -1 n=34 Participants SGI-110 30 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle.	Dose Level -1G SGI-110 30 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.	Dose Level 1G SGI-110 45 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.
Overall Survival	7.15 months Interval 6.6 to 8.02	7.66 months Interval 4.83 to 9.36	—	—

SECONDARY outcome

Timeframe: Assessed until disease progression, up to 3 years

Population: ORR only assessed for Phase 2. 5 from Arm A and 2 from Arm B were excluded from response rate analysis as they didn't get a follow-up scan. 18 subjects in Arm B were eligible to "crossover" to receive Arm A treatment. They were not included in the number analyzed in Arm A because they were not assessed for objective response after Arm A treatment.

Objective Response Rate (ORR) is defined as the number of subjects achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. CR = disappearance of all target lesions, PR = at least 30% decrease in the sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=57 Participants SGI-110 45 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle.	Dose Level -1 n=32 Participants SGI-110 30 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle.	Dose Level -1G SGI-110 30 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.	Dose Level 1G SGI-110 45 mg/m\^2 subcutaneously on days 1-5 of each 28-day cycle Irinotecan 125 mg/m\^2 IV on days 8 and 15 of each 28-day cycle. Growth Factor Support with Filgrastim and/or Pegfilgrastim given during Cycle 1 and in subsequent cycles per clinician judgement.
Objective Response Rate	1 Participants	0 Participants	—	—

Adverse Events

Phase 1: Dose Level 1

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase 1: Dose Level -1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1: Dose Level -1G

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase 1: Dose Level 1G

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Phase 2: Arm A SGI-110 + Irinotecan

Serious events: 15 serious events

Other events: 58 other events

Deaths: 3 deaths

Phase 2: "Crossover" to Arm A From Arm B

Serious events: 8 serious events

Other events: 18 other events

Deaths: 0 deaths

Phase 2: Arm B Regorafenib or TAS-102

Serious events: 1 serious events

Other events: 30 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: Dose Level 1 n=6 participants at risk Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1 n=3 participants at risk Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1G n=7 participants at risk Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 1: Dose Level 1G n=6 participants at risk Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 2: Arm A SGI-110 + Irinotecan n=62 participants at risk SGI-110 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.	Phase 2: "Crossover" to Arm A From Arm B n=18 participants at risk Per protocol, Arm B subjects were given the option to "crossover" and receive Arm A study drugs after disease progression on Arm B. 18 Arm B subjects received Arm A study drugs after initial progression. SGI-110 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.	Phase 2: Arm B Regorafenib or TAS-102 n=34 participants at risk Subjects received either regorafenib or TAS-102. Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m\^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Blood and lymphatic system disorders Febrile neutropenia	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	28.6% 2/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	6.5% 4/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	11.1% 2/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Colitis	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.3% 1/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	3.2% 2/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Nausea	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	2.9% 1/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
General disorders Fatigue or Malaise	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
General disorders Fever	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Infections and infestations Bacteremia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Infections and infestations Sepsis	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	6.5% 4/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 3/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Infections and infestations Skin infection	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Infections and infestations Urinary tract infection	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Infections and infestations Wound infection	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Investigations Blood bilirubin increased	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Vascular disorders Hypotension	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.

Other adverse events

Other adverse events
Measure	Phase 1: Dose Level 1 n=6 participants at risk Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1 n=3 participants at risk Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle.	Phase 1: Dose Level -1G n=7 participants at risk Guadecitabine (SGI-110) 30 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 1: Dose Level 1G n=6 participants at risk Guadecitabine (SGI-110) 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond.	Phase 2: Arm A SGI-110 + Irinotecan n=62 participants at risk SGI-110 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.	Phase 2: "Crossover" to Arm A From Arm B n=18 participants at risk Per protocol, Arm B subjects were given the option to "crossover" and receive Arm A study drugs after disease progression on Arm B. 18 Arm B subjects received Arm A study drugs after initial progression. SGI-110 45 mg/m\^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m\^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.	Phase 2: Arm B Regorafenib or TAS-102 n=34 participants at risk Subjects received either regorafenib or TAS-102. Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m\^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Blood and lymphatic system disorders Anemia	66.7% 4/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	66.7% 2/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	71.4% 5/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	59.7% 37/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	44.4% 8/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	44.1% 15/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	66.7% 2/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 3/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Blood and lymphatic system disorders Lymphopenia	83.3% 5/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	57.1% 4/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	11.3% 7/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 3/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.7% 5/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Blood and lymphatic system disorders Neutropenia	100.0% 6/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	100.0% 3/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	71.4% 5/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	66.7% 4/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	43.5% 27/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	55.6% 10/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	35.3% 12/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	42.9% 3/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	32.3% 20/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 6/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	8.8% 3/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Blood and lymphatic system disorders Leukopenia	100.0% 6/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	71.4% 5/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	66.7% 4/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	45.2% 28/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 6/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	32.4% 11/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	2.9% 1/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Endocrine disorders Glucose intolerance	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Abdominal pain	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	28.6% 2/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	8.1% 5/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 3/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	17.6% 6/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Constipation	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	6.5% 4/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	8.8% 3/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	66.7% 2/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	42.9% 3/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	38.7% 24/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 6/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	20.6% 7/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	8.8% 3/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Mucositis oral	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	11.1% 2/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	2.9% 1/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Nausea	83.3% 5/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	85.7% 6/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	66.7% 4/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	45.2% 28/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	27.8% 5/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	32.4% 11/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	100.0% 3/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	57.1% 4/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.5% 9/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	22.2% 4/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.7% 5/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
General disorders Chills	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.3% 1/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
General disorders Edema limbs	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	57.1% 4/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
General disorders Fatigue or malaise	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	66.7% 2/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	57.1% 4/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	83.3% 5/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	59.7% 37/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	55.6% 10/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	41.2% 14/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
General disorders Fever	66.7% 4/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	28.6% 2/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	12.9% 8/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	2.9% 1/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
General disorders Injection site reaction	66.7% 4/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	71.4% 5/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	66.7% 4/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	19.4% 12/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	27.8% 5/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Infections and infestations Abscess or skin infection	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.3% 1/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Injury, poisoning and procedural complications Bruising	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.3% 1/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Investigations Alkaline phosphatase increased	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	71.4% 5/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	12.9% 8/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Investigations ALT increased	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	3.2% 2/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	8.8% 3/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Investigations AST increased	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	57.1% 4/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	3.2% 2/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	11.1% 2/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.9% 2/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Investigations Blood bilirubin increased	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	8.1% 5/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.9% 2/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Investigations Weight loss	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	8.1% 5/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	2.9% 1/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Metabolism and nutrition disorders Anorexia	66.7% 4/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	42.9% 3/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	22.6% 14/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	11.1% 2/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	32.4% 11/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	28.6% 2/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	2.9% 1/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Investigations Hyperglycemia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	3.2% 2/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Investigations Hypocalcemia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.9% 2/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Investigations Hypophosphatemia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.9% 2/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.3% 1/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	2.9% 1/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	28.6% 2/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	4.8% 3/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Nervous system disorders Dizziness	16.7% 1/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	28.6% 2/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	4.8% 3/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Nervous system disorders Dysgeusia	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.3% 1/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	4.8% 3/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.9% 2/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Nervous system disorders Headache	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Skin and subcutaneous tissue disorders Alopecia	50.0% 3/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	28.6% 2/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 2/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	17.7% 11/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	2.9% 1/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.9% 2/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Vascular disorders Hypertension	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.9% 2/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
Vascular disorders Hypotension	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	33.3% 1/3 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	14.3% 1/7 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/6 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	1.6% 1/62 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	5.6% 1/18 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.	0.00% 0/34 • Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months 18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.

Additional Information

Dr. Nilofer Azad

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 410-614-9169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigators (PIs) from participating sites must provide the Johns Hopkins PI with a copy of any proposed publication for review and comment at least 30 days prior to submission.
Publication restrictions are in place

Restriction type: OTHER