Trial Outcomes & Findings for Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies (NCT NCT02030067)

NCT ID: NCT02030067

Last Updated: 2023-12-06

Results Overview

Number of subjects participating in Phase 1 that experienced a DLT during the first cycle of treatment (28 days)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 127 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2023-12-06

Participant Flow

3 patients enrolled in the Phase 2 portion of the study discontinued prior to dosing. Therefore 124 patients started the study rather than 127 patients as listed in the protocol section.

Participant milestones

Measure	RX-3117 30 mg, 3 Times/Week Subjects will receive 30 mg RX-3117, 3 times/week	RX-3117 60 mg, 3 Times/Week Subjects will receive 60 mg RX-3117 3 times/week	RX-3117 100 mg, 3 Times/Week Subjects will receive 100 mg RX-3117 3 times/week	RX-3117 150 mg, 3 Times/Week Subjects will receive 150 mg RX-3117, 3 times/week	RX-3117 200 mg, 3 Times/Week Subjects will receive 200 mg of RX-3117, 3 times/week	RX-3117 500 mg, 3 Times/Week Subjects will receive 500 mg RX-3117, 3 times/week	RX-3117 1000 mg, 3 Times/Week Subjects received 1000 mg RX-3117, 3 times/week	RX 3117 1500 mg, 3 Times/Week Subjects received 1500 mg RX-3117, 3 times/week	RX-3117 2000 mg, 3 Times/Week Subjects received 2000 mg RX-3117, 3 times/week	RX-3117 500 mg, 5 Times/Week Subjects receivved 500 mg RX-3117, 5 times/week	RX-3117 700 mg, 5 Times/Week Subjects received 700 mg RX-3117, 5 times/week	RX-3117 500 mg, 7 Times/Week Subjects received 500 mg RX-3117, 7 times/week	RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study) Subjects received MTD of 700 mg RX-3117, 5 times/week
Overall Study STARTED	1	1	3	3	3	3	3	4	6	3	11	3	80
Overall Study COMPLETED	0	0	1	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	1	1	2	3	3	3	3	4	6	3	11	3	80

Reasons for withdrawal

Measure	RX-3117 30 mg, 3 Times/Week Subjects will receive 30 mg RX-3117, 3 times/week	RX-3117 60 mg, 3 Times/Week Subjects will receive 60 mg RX-3117 3 times/week	RX-3117 100 mg, 3 Times/Week Subjects will receive 100 mg RX-3117 3 times/week	RX-3117 150 mg, 3 Times/Week Subjects will receive 150 mg RX-3117, 3 times/week	RX-3117 200 mg, 3 Times/Week Subjects will receive 200 mg of RX-3117, 3 times/week	RX-3117 500 mg, 3 Times/Week Subjects will receive 500 mg RX-3117, 3 times/week	RX-3117 1000 mg, 3 Times/Week Subjects received 1000 mg RX-3117, 3 times/week	RX 3117 1500 mg, 3 Times/Week Subjects received 1500 mg RX-3117, 3 times/week	RX-3117 2000 mg, 3 Times/Week Subjects received 2000 mg RX-3117, 3 times/week	RX-3117 500 mg, 5 Times/Week Subjects receivved 500 mg RX-3117, 5 times/week	RX-3117 700 mg, 5 Times/Week Subjects received 700 mg RX-3117, 5 times/week	RX-3117 500 mg, 7 Times/Week Subjects received 500 mg RX-3117, 7 times/week	RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study) Subjects received MTD of 700 mg RX-3117, 5 times/week
Overall Study Disease Progression	1	1	2	2	3	2	3	3	4	3	7	2	59
Overall Study Withdrawal by Subject	0	0	0	1	0	0	0	1	0	0	3	0	6
Overall Study Physician Decision	0	0	0	0	0	0	0	0	0	0	1	0	3
Overall Study other reasons	0	0	0	0	0	1	0	0	2	0	0	0	4
Overall Study Adverse Event	0	0	0	0	0	0	0	0	0	0	0	1	8

Baseline Characteristics

Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies

Baseline characteristics by cohort

Measure	RX-3117 30 mg 3 Times/Week n=1 Participants Patient received 30 mg RX-3117 3 times/week	RX-3117 60 mg 3 Times/Week n=1 Participants Patient received 60 mg RX-3117 3 times/week	RX-3117 100 mg 3 Times/Week n=3 Participants Patients received 100 mg RX-3117 3 times/week	RX-3117 150 mg 3 Times/Week n=3 Participants Patients received 150 mg RX-3117 3 times/week	RX-3117 200 mg 3 Times/Week n=3 Participants Patients received 200 mg RX-3117 3 times/week	RX-3117 500 mg 3 Times/Week n=3 Participants Patients received 500 mg RX-3117 3 times/week	RX-3117 1000 mg 3 Times/Week n=3 Participants Patients received 1000 mg RX-3117 3 times/week	RX-3117 1500 mg 3 Times/Week n=4 Participants Patients received 1500 mg RX-3117 3 times/week	RX-3117 2000 mg 3 Times/Week n=6 Participants Patients received 2000 mg RX-3117 3 times/week	RX-3117 500 mg 5 Times/Week n=3 Participants Patients received 500 mg RX-3117 5 times/week	RX-3117 700 mg 5 Times/Week n=11 Participants Patients received 700 mg RX-3117 5 times/week	RX-3117 500 mg 7 Times/Week n=3 Participants Patients received RX-3117 500 mg 7 Times/Week	RX-3117 700 mg 5 Times/Week (Phase 2) n=80 Participants Patients received 700 mg RX-3117 5 times/week	Total n=124 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 0 • n=5 Participants	66.0 years STANDARD_DEVIATION 0 • n=7 Participants	65.3 years STANDARD_DEVIATION 5.86 • n=5 Participants	67.0 years STANDARD_DEVIATION 4.58 • n=4 Participants	68.0 years STANDARD_DEVIATION 6.24 • n=21 Participants	53.7 years STANDARD_DEVIATION 7.57 • n=10 Participants	54.3 years STANDARD_DEVIATION 4.16 • n=115 Participants	63.3 years STANDARD_DEVIATION 16.50 • n=6 Participants	61.0 years STANDARD_DEVIATION 13.30 • n=6 Participants	62.0 years STANDARD_DEVIATION 13.08 • n=64 Participants	58.0 years STANDARD_DEVIATION 10.87 • n=17 Participants	67.0 years STANDARD_DEVIATION 6.56 • n=21 Participants	67.6 years STANDARD_DEVIATION 9.11 • n=22 Participants	65.37 years STANDARD_DEVIATION 9.84 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=6 Participants	4 Participants n=6 Participants	2 Participants n=64 Participants	8 Participants n=17 Participants	3 Participants n=21 Participants	34 Participants n=22 Participants	63 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=64 Participants	3 Participants n=17 Participants	0 Participants n=21 Participants	46 Participants n=22 Participants	61 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=64 Participants	5 Participants n=17 Participants	1 Participants n=21 Participants	14 Participants n=22 Participants	31 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	2 Participants n=64 Participants	6 Participants n=17 Participants	2 Participants n=21 Participants	63 Participants n=22 Participants	90 Participants n=8 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	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	3 Participants n=22 Participants	3 Participants n=8 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	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	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	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	3 Participants n=22 Participants	4 Participants n=8 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	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	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	1 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	8 Participants n=22 Participants	10 Participants n=8 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	3 Participants n=64 Participants	9 Participants n=17 Participants	2 Participants n=21 Participants	64 Participants n=22 Participants	99 Participants n=8 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	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 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	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	2 Participants n=17 Participants	1 Participants n=21 Participants	5 Participants n=22 Participants	11 Participants n=8 Participants

PRIMARY outcome

Timeframe: 28 days

Number of subjects participating in Phase 1 that experienced a DLT during the first cycle of treatment (28 days)

Outcome measures

Measure	RX-3117 30 mg, 3 Times/Week n=1 Participants Subjects will receive 30 mg RX-3117, 3 times/week	RX-3117 60 mg, 3 Times/Week n=1 Participants Subjects will receive 60 mg RX-3117 3 times/week	RX-3117 100 mg, 3 Times/Week n=3 Participants Subjects will receive 100 mg RX-3117 3 times/week	RX-3117 150 mg, 3 Times/Week n=3 Participants Subjects will receive 150 mg RX-3117, 3 times/week	RX-3117 200 mg, 3 Times/Week n=3 Participants Subjects will receive 200 mg of RX-3117, 3 times/week	RX-3117 500 mg, 3 Times/Week n=3 Participants Subjects will receive 500 mg RX-3117, 3 times/week	RX-3117 1000 mg, 3 Times/Week n=3 Participants Subjects received 1000 mg RX-3117, 3 times/week	RX 3117 1500 mg, 3 Times/Week n=4 Participants Subjects received 1500 mg RX-3117, 3 times/week	RX-3117 2000 mg, 3 Times/Week n=6 Participants Subjects received 2000 mg RX-3117, 3 times/week	RX-3117 500 mg, 5 Times/Week n=3 Participants Subjects receivved 500 mg RX-3117, 5 times/week	RX-3117 700 mg, 5 Times/Week n=11 Participants Subjects received 700 mg RX-3117, 5 times/week	RX-3117 500 mg, 7 Times/Week n=3 Participants Subjects received 500 mg RX-3117, 7 times/week	RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study) Subjects received MTD of 700 mg RX-3117, 5 times/week
Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	—

PRIMARY outcome

Timeframe: through study completion, up to 224 days (8 cycles of treatment)

Population: Population includes those subjects participating in the dose escalation phase of the study (Phase 1)

Number of subjects participating in Phase 1 that experience any SAEs

Outcome measures

Measure	RX-3117 30 mg, 3 Times/Week n=1 Participants Subjects will receive 30 mg RX-3117, 3 times/week	RX-3117 60 mg, 3 Times/Week n=1 Participants Subjects will receive 60 mg RX-3117 3 times/week	RX-3117 100 mg, 3 Times/Week n=3 Participants Subjects will receive 100 mg RX-3117 3 times/week	RX-3117 150 mg, 3 Times/Week n=3 Participants Subjects will receive 150 mg RX-3117, 3 times/week	RX-3117 200 mg, 3 Times/Week n=3 Participants Subjects will receive 200 mg of RX-3117, 3 times/week	RX-3117 500 mg, 3 Times/Week n=3 Participants Subjects will receive 500 mg RX-3117, 3 times/week	RX-3117 1000 mg, 3 Times/Week n=3 Participants Subjects received 1000 mg RX-3117, 3 times/week	RX 3117 1500 mg, 3 Times/Week n=4 Participants Subjects received 1500 mg RX-3117, 3 times/week	RX-3117 2000 mg, 3 Times/Week n=6 Participants Subjects received 2000 mg RX-3117, 3 times/week	RX-3117 500 mg, 5 Times/Week n=3 Participants Subjects receivved 500 mg RX-3117, 5 times/week	RX-3117 700 mg, 5 Times/Week n=11 Participants Subjects received 700 mg RX-3117, 5 times/week	RX-3117 500 mg, 7 Times/Week n=3 Participants Subjects received 500 mg RX-3117, 7 times/week	RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study) Subjects received MTD of 700 mg RX-3117, 5 times/week
Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	5 Participants	1 Participants	—

PRIMARY outcome

Timeframe: through study completion, up to 224 days (8 cycles of treatment)

Population: Population includes subjects in the dose escalation phase of the study (Phase 1)

Number of subjects participating in Phase 1 of study that discontinued study treatment due to a treatment emergent adverse event.

Outcome measures

Measure	RX-3117 30 mg, 3 Times/Week n=1 Participants Subjects will receive 30 mg RX-3117, 3 times/week	RX-3117 60 mg, 3 Times/Week n=1 Participants Subjects will receive 60 mg RX-3117 3 times/week	RX-3117 100 mg, 3 Times/Week n=3 Participants Subjects will receive 100 mg RX-3117 3 times/week	RX-3117 150 mg, 3 Times/Week n=3 Participants Subjects will receive 150 mg RX-3117, 3 times/week	RX-3117 200 mg, 3 Times/Week n=3 Participants Subjects will receive 200 mg of RX-3117, 3 times/week	RX-3117 500 mg, 3 Times/Week n=3 Participants Subjects will receive 500 mg RX-3117, 3 times/week	RX-3117 1000 mg, 3 Times/Week n=3 Participants Subjects received 1000 mg RX-3117, 3 times/week	RX 3117 1500 mg, 3 Times/Week n=4 Participants Subjects received 1500 mg RX-3117, 3 times/week	RX-3117 2000 mg, 3 Times/Week n=6 Participants Subjects received 2000 mg RX-3117, 3 times/week	RX-3117 500 mg, 5 Times/Week n=3 Participants Subjects receivved 500 mg RX-3117, 5 times/week	RX-3117 700 mg, 5 Times/Week n=11 Participants Subjects received 700 mg RX-3117, 5 times/week	RX-3117 500 mg, 7 Times/Week n=3 Participants Subjects received 500 mg RX-3117, 7 times/week	RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study) Subjects received MTD of 700 mg RX-3117, 5 times/week
Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—

PRIMARY outcome

Timeframe: through study completion, up to 224 days (8 cycles of treatment)

Population: Population includes subjects participating in the dose escalation phase of the study (Phase 1)

Number of subjects that experience any treatment-related adverse event.

Outcome measures

Measure	RX-3117 30 mg, 3 Times/Week n=1 Participants Subjects will receive 30 mg RX-3117, 3 times/week	RX-3117 60 mg, 3 Times/Week n=1 Participants Subjects will receive 60 mg RX-3117 3 times/week	RX-3117 100 mg, 3 Times/Week n=3 Participants Subjects will receive 100 mg RX-3117 3 times/week	RX-3117 150 mg, 3 Times/Week n=3 Participants Subjects will receive 150 mg RX-3117, 3 times/week	RX-3117 200 mg, 3 Times/Week n=3 Participants Subjects will receive 200 mg of RX-3117, 3 times/week	RX-3117 500 mg, 3 Times/Week n=3 Participants Subjects will receive 500 mg RX-3117, 3 times/week	RX-3117 1000 mg, 3 Times/Week n=3 Participants Subjects received 1000 mg RX-3117, 3 times/week	RX 3117 1500 mg, 3 Times/Week n=4 Participants Subjects received 1500 mg RX-3117, 3 times/week	RX-3117 2000 mg, 3 Times/Week n=6 Participants Subjects received 2000 mg RX-3117, 3 times/week	RX-3117 500 mg, 5 Times/Week n=3 Participants Subjects receivved 500 mg RX-3117, 5 times/week	RX-3117 700 mg, 5 Times/Week n=11 Participants Subjects received 700 mg RX-3117, 5 times/week	RX-3117 500 mg, 7 Times/Week n=3 Participants Subjects received 500 mg RX-3117, 7 times/week	RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study) Subjects received MTD of 700 mg RX-3117, 5 times/week
Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1	0 Participants	1 Participants	2 Participants	3 Participants	3 Participants	0 Participants	2 Participants	3 Participants	6 Participants	3 Participants	9 Participants	3 Participants	—

PRIMARY outcome

Timeframe: 4 months

Population: Patients participating in Phase 2 of the study, which included 41 pancreatic cancer and 31 bladder cancer patients

Progression Free Survival in Phase 2 of the study for pancreatic and bladder cancer subjects.

Outcome measures

Measure	RX-3117 30 mg, 3 Times/Week n=72 Participants Subjects will receive 30 mg RX-3117, 3 times/week	RX-3117 60 mg, 3 Times/Week Subjects will receive 60 mg RX-3117 3 times/week	RX-3117 100 mg, 3 Times/Week Subjects will receive 100 mg RX-3117 3 times/week	RX-3117 150 mg, 3 Times/Week Subjects will receive 150 mg RX-3117, 3 times/week	RX-3117 200 mg, 3 Times/Week Subjects will receive 200 mg of RX-3117, 3 times/week	RX-3117 500 mg, 3 Times/Week Subjects will receive 500 mg RX-3117, 3 times/week	RX-3117 1000 mg, 3 Times/Week Subjects received 1000 mg RX-3117, 3 times/week	RX 3117 1500 mg, 3 Times/Week Subjects received 1500 mg RX-3117, 3 times/week	RX-3117 2000 mg, 3 Times/Week Subjects received 2000 mg RX-3117, 3 times/week	RX-3117 500 mg, 5 Times/Week Subjects receivved 500 mg RX-3117, 5 times/week	RX-3117 700 mg, 5 Times/Week Subjects received 700 mg RX-3117, 5 times/week	RX-3117 500 mg, 7 Times/Week Subjects received 500 mg RX-3117, 7 times/week	RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study) Subjects received MTD of 700 mg RX-3117, 5 times/week
Progression Free Survival (Phase 2) Pancreatic cancer patients	4.7 weeks Interval 3.14 to 8.0	—	—	—	—	—	—	—	—	—	—	—	—
Progression Free Survival (Phase 2) Bladder cancer patients	7.7 weeks Interval 7.14 to 13.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours after oral administration in Cycle 1 Days 1 and 15

Population: No pharmacokinetic analysis was conducted

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and at 4, 8, 12, 16 and 32 weeks

Population: Evaluable for Tumor Response Analysis Set (includes Bladder and Pancreatic patients in Phase 2)

Best Overall Response Rate (includes Complete Response, Partial Response, and Stable Disease)

Outcome measures

Measure	RX-3117 30 mg, 3 Times/Week n=72 Participants Subjects will receive 30 mg RX-3117, 3 times/week	RX-3117 60 mg, 3 Times/Week Subjects will receive 60 mg RX-3117 3 times/week	RX-3117 100 mg, 3 Times/Week Subjects will receive 100 mg RX-3117 3 times/week	RX-3117 150 mg, 3 Times/Week Subjects will receive 150 mg RX-3117, 3 times/week	RX-3117 200 mg, 3 Times/Week Subjects will receive 200 mg of RX-3117, 3 times/week	RX-3117 500 mg, 3 Times/Week Subjects will receive 500 mg RX-3117, 3 times/week	RX-3117 1000 mg, 3 Times/Week Subjects received 1000 mg RX-3117, 3 times/week	RX 3117 1500 mg, 3 Times/Week Subjects received 1500 mg RX-3117, 3 times/week	RX-3117 2000 mg, 3 Times/Week Subjects received 2000 mg RX-3117, 3 times/week	RX-3117 500 mg, 5 Times/Week Subjects receivved 500 mg RX-3117, 5 times/week	RX-3117 700 mg, 5 Times/Week Subjects received 700 mg RX-3117, 5 times/week	RX-3117 500 mg, 7 Times/Week Subjects received 500 mg RX-3117, 7 times/week	RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study) Subjects received MTD of 700 mg RX-3117, 5 times/week
Best Overall Response Rate (Phase 2) pancreatic subjects	26.8 percentage Interval 14.2 to 42.9	—	—	—	—	—	—	—	—	—	—	—	—
Best Overall Response Rate (Phase 2) bladder subjects	45.2 percentage Interval 27.3 to 64.0	—	—	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4, 8, 12, 16 and 32 weeks

Population: Analysis of biomarker data not conducted. Biomarker samples were not analyzed due to previous sponsor terminating clinical program.

Analysis of biomarker data not conducted. Biomarker samples were not analyzed due to previous sponsor terminating clinical program.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1 (Dose Escalation) 30 mg 3x/Week

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 60 mg 3x/Week

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 100 mg 3x/Week

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 150 mg 3x/Week

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 200 mg 3x/Week

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 500 mg 3x/Week

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 1000 mg 3x/Week

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 1500 mg 3x/Week

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 2000 mg 3x/Week

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 500 mg 5x/Week

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 (Dose Escalation) 700 mg 5x/Week

Serious events: 5 serious events

Other events: 11 other events

Deaths: 1 deaths

Phase 1 (Dose Escalation) 500 mg 7x/Week

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 2 700 mg

Serious events: 29 serious events

Other events: 78 other events

Deaths: 8 deaths

Serious adverse events

Measure	Phase 1 (Dose Escalation) 30 mg 3x/Week n=1 participants at risk RX-3117 30 mg administered 3 times/week	Phase 1 (Dose Escalation) 60 mg 3x/Week n=1 participants at risk RX-3117 60 mg administered 3 times/week	Phase 1 (Dose Escalation) 100 mg 3x/Week n=3 participants at risk RX-3117 100 mg administered 3 times/week	Phase 1 (Dose Escalation) 150 mg 3x/Week n=3 participants at risk RX-3117 150 mg administered 3 times/week	Phase 1 (Dose Escalation) 200 mg 3x/Week n=3 participants at risk RX-3117 200 mg administered 3 times/week	Phase 1 (Dose Escalation) 500 mg 3x/Week n=3 participants at risk RX-3117 500 mg administered 3 times/week	Phase 1 (Dose Escalation) 1000 mg 3x/Week n=3 participants at risk RX-3117 1000 mg administered 3 times/week	Phase 1 (Dose Escalation) 1500 mg 3x/Week n=4 participants at risk RX-3117 1500 mg administered 3 times/week	Phase 1 (Dose Escalation) 2000 mg 3x/Week n=6 participants at risk RX-3117 2000 mg administered 3 times/week	Phase 1 (Dose Escalation) 500 mg 5x/Week n=3 participants at risk RX-3117 500 mg administered 5 times/week	Phase 1 (Dose Escalation) 700 mg 5x/Week n=11 participants at risk RX-3117 700 mg administered 5 times/week	Phase 1 (Dose Escalation) 500 mg 7x/Week n=3 participants at risk RX-3117 500 mg administered 7 times/week	Phase 2 700 mg n=80 participants at risk RX-3117 700 mg administered 5 times/week
Infections and infestations pneumonia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders haematemesis	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders large intestinal obstruction	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders small intestinal obstruction	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders stomatitis	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders vomiting	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders abdominal pain	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders gastrointestinal haemorrhage	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	3.8% 3/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders abdominal distension	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	2.5% 2/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders ascites	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	2.5% 2/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders abdominal pain upper	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders colitis	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders haematochezia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders pancreatitis	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Infections and infestations peritonitis bacterial	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Metabolism and nutrition disorders hypoglycemia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	100.0% 1/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Metabolism and nutrition disorders hyponatraemia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Blood and lymphatic system disorders anemia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Blood and lymphatic system disorders neutropenia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Hepatobiliary disorders cholangitis	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Nervous system disorders cerebrovascular accident	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Renal and urinary disorders urinary tract obstruction	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Respiratory, thoracic and mediastinal disorders pleurisy	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Musculoskeletal and connective tissue disorders back pain	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	2.5% 2/80 • up to 224 days (8 cycles of treatment)
Musculoskeletal and connective tissue disorders musculoskeletal pain	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Respiratory, thoracic and mediastinal disorders dyspnoea	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Respiratory, thoracic and mediastinal disorders hypoxia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Respiratory, thoracic and mediastinal disorders pleural effusion	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Respiratory, thoracic and mediastinal disorders pulmonary arterial hypertension	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
General disorders disease progression	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	2.5% 2/80 • up to 224 days (8 cycles of treatment)
General disorders local swelling	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Infections and infestations sepsis	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	2.5% 2/80 • up to 224 days (8 cycles of treatment)
Infections and infestations neutropenic sepsis	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) malignant neoplasm progression	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	2.5% 2/80 • up to 224 days (8 cycles of treatment)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ureteric cancer metastatic	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Injury, poisoning and procedural complications muscle strain	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Injury, poisoning and procedural complications spinal compression fracture	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Nervous system disorders cervical cord compression	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Blood and lymphatic system disorders febrile neutropenia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Cardiac disorders cardio-respiratory arrest	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)
Metabolism and nutrition disorders hypophagia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	1.2% 1/80 • up to 224 days (8 cycles of treatment)

Other adverse events

Measure	Phase 1 (Dose Escalation) 30 mg 3x/Week n=1 participants at risk RX-3117 30 mg administered 3 times/week	Phase 1 (Dose Escalation) 60 mg 3x/Week n=1 participants at risk RX-3117 60 mg administered 3 times/week	Phase 1 (Dose Escalation) 100 mg 3x/Week n=3 participants at risk RX-3117 100 mg administered 3 times/week	Phase 1 (Dose Escalation) 150 mg 3x/Week n=3 participants at risk RX-3117 150 mg administered 3 times/week	Phase 1 (Dose Escalation) 200 mg 3x/Week n=3 participants at risk RX-3117 200 mg administered 3 times/week	Phase 1 (Dose Escalation) 500 mg 3x/Week n=3 participants at risk RX-3117 500 mg administered 3 times/week	Phase 1 (Dose Escalation) 1000 mg 3x/Week n=3 participants at risk RX-3117 1000 mg administered 3 times/week	Phase 1 (Dose Escalation) 1500 mg 3x/Week n=4 participants at risk RX-3117 1500 mg administered 3 times/week	Phase 1 (Dose Escalation) 2000 mg 3x/Week n=6 participants at risk RX-3117 2000 mg administered 3 times/week	Phase 1 (Dose Escalation) 500 mg 5x/Week n=3 participants at risk RX-3117 500 mg administered 5 times/week	Phase 1 (Dose Escalation) 700 mg 5x/Week n=11 participants at risk RX-3117 700 mg administered 5 times/week	Phase 1 (Dose Escalation) 500 mg 7x/Week n=3 participants at risk RX-3117 500 mg administered 7 times/week	Phase 2 700 mg n=80 participants at risk RX-3117 700 mg administered 5 times/week
Respiratory, thoracic and mediastinal disorders epistaxis	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Blood and lymphatic system disorders anaemia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	50.0% 3/6 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	36.4% 4/11 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	47.5% 38/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders nausea	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	25.0% 1/4 • up to 224 days (8 cycles of treatment)	33.3% 2/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	54.5% 6/11 • up to 224 days (8 cycles of treatment)	100.0% 3/3 • up to 224 days (8 cycles of treatment)	27.5% 22/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders diarrhoea	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	46.2% 37/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders vomiting	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	36.4% 4/11 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	17.5% 14/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders abdominal distension	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders abdominal pain	100.0% 1/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	27.3% 3/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	28.7% 23/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders constipation	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	18.2% 2/11 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	11.2% 9/80 • up to 224 days (8 cycles of treatment)
General disorders fatigue	0.00% 0/1 • up to 224 days (8 cycles of treatment)	100.0% 1/1 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	75.0% 3/4 • up to 224 days (8 cycles of treatment)	66.7% 4/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	54.5% 6/11 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	48.8% 39/80 • up to 224 days (8 cycles of treatment)
General disorders oedema peripheral	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	25.0% 1/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	11.2% 9/80 • up to 224 days (8 cycles of treatment)
Metabolism and nutrition disorders decreased appetite	0.00% 0/1 • up to 224 days (8 cycles of treatment)	100.0% 1/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	27.3% 3/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	18.8% 15/80 • up to 224 days (8 cycles of treatment)
Metabolism and nutrition disorders hypokalemia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	8.8% 7/80 • up to 224 days (8 cycles of treatment)
Metabolism and nutrition disorders hypomagnesaemia	100.0% 1/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Blood and lymphatic system disorders neutropenia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	12.5% 10/80 • up to 224 days (8 cycles of treatment)
Musculoskeletal and connective tissue disorders back pain	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	12.5% 10/80 • up to 224 days (8 cycles of treatment)
Respiratory, thoracic and mediastinal disorders dyspnoea	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	10.0% 8/80 • up to 224 days (8 cycles of treatment)
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/1 • up to 224 days (8 cycles of treatment)	100.0% 1/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	18.2% 2/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	8.8% 7/80 • up to 224 days (8 cycles of treatment)
Nervous system disorders dizziness	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	12.5% 10/80 • up to 224 days (8 cycles of treatment)
Infections and infestations urinary tract infection	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	10.0% 8/80 • up to 224 days (8 cycles of treatment)
General disorders Pyrexia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	25.0% 1/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Investigations blood alkaline phosphatase increased	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	33.3% 2/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Investigations lymphocyte count decreased	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	33.3% 2/6 • up to 224 days (8 cycles of treatment)	66.7% 2/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/80 • up to 224 days (8 cycles of treatment)
Metabolism and nutrition disorders hyponatraemia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	16.7% 1/6 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	9.1% 1/11 • up to 224 days (8 cycles of treatment)	33.3% 1/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Blood and lymphatic system disorders leukopenia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Blood and lymphatic system disorders thrombocytopenia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders abdominal pain upper	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders ascites	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Gastrointestinal disorders flatulence	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
General disorders chills	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Investigations aspartate aminotransferase increased	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Investigations neutrophil count decreased	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Investigations platelet count decreased	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Investigations white blood cell count decreased	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Metabolism and nutrition disorders abnormal loss of weight	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Metabolism and nutrition disorders dehydration	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Musculoskeletal and connective tissue disorders musculoskeletal pain	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	6.2% 5/80 • up to 224 days (8 cycles of treatment)
Musculoskeletal and connective tissue disorders myalgia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Musculoskeletal and connective tissue disorders pain in extremity	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Nervous system disorders headache	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Psychiatric disorders insomnia	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	7.5% 6/80 • up to 224 days (8 cycles of treatment)
Renal and urinary disorders dysuria	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Respiratory, thoracic and mediastinal disorders upper-airway cough syndrome	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	5.0% 4/80 • up to 224 days (8 cycles of treatment)
Skin and subcutaneous tissue disorders rash	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/1 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/4 • up to 224 days (8 cycles of treatment)	0.00% 0/6 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	0.00% 0/11 • up to 224 days (8 cycles of treatment)	0.00% 0/3 • up to 224 days (8 cycles of treatment)	7.5% 6/80 • up to 224 days (8 cycles of treatment)

Additional Information

Director Drug Development and Regulatory Affairs

Processa Pharmaceuticals

Phone: 443-631-6614

Email: pfranks@processapharmaceuticals.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place