Trial Outcomes & Findings for Pazopanib/Doxil in Adv Relapsed Plat Sensitive or Resistant Ovarian, Fallopian or Primary Peritoneal Adenocarcinoma (NCT NCT01035658)

Last Updated: 2021-10-28

Results Overview

The MTD of the drug combination will be determined as the highest dose at which ≤1 of 6 subjects experiences a Grade 3 or Grade 4 DLT according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

18 months

Results posted on

2021-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 1 Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level -1 Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 1 Sequential Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 2 Sequential Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle
Overall Study STARTED	5	8	3	6
Overall Study COMPLETED	5	8	3	6
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pazopanib/Doxil in Adv Relapsed Plat Sensitive or Resistant Ovarian, Fallopian or Primary Peritoneal Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 n=5 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level -1 n=8 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 1 Sequential n=3 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 2 Sequential n=6 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Total n=22 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	74 years n=7 Participants	64 years n=5 Participants	57 years n=4 Participants	64 years n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	22 Participants n=21 Participants
Sex: Female, Male Male	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
Region of Enrollment United States	5 participants n=5 Participants	8 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants	22 participants n=21 Participants

PRIMARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Phase 1 n=22 Participants All patients in Phase I (this section contains the Maximum Tolerated Dose)	Dose Level -1 Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 1 Sequential Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 2 Sequential Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle
Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin Pazopanib	400 mg	—	—	—
Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin Liposomal doxorubicin	30 mg	—	—	—

PRIMARY outcome

Timeframe: 18 months

As requested, this outcome measure reports the number of patients experiencing dose limiting toxicities (DLTs) in the Phase I portion of the study

Outcome measures

Outcome measures
Measure	Phase 1 n=5 Participants All patients in Phase I (this section contains the Maximum Tolerated Dose)	Dose Level -1 n=8 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 1 Sequential n=3 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 2 Sequential n=6 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle
Phase I - Dose Limiting Toxicities	3 participants	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 18 months

Population: Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.

Defined as from date of randomization until objective tumor progression or death. Response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) and CA-125 response in patients using the Rustin Criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: Two patients stopped treatment prior to first reevaluation and hence were not included in the analysis. one patient's Recurrence status is unknown and thus was not evaluable

The response rate in the subsets of patients with platinum-sensitive and platinum-refractory ovarian carcinoma is evaluated as a measure of efficacy of pazopanib/liposomal doxorubicin. Response rate ( Percentage of patients whose disease decreased (Partial response - PR) and/or disappears (Complete response - CR) after treatment) was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) and CA-125 response in patients using the Rustin Criteria. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is \>= 30% decrease in the sum of longest diameter(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions.

Outcome measures

Outcome measures
Measure	Phase 1 n=8 Participants All patients in Phase I (this section contains the Maximum Tolerated Dose)	Dose Level -1 n=11 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 1 Sequential Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 2 Sequential Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle
Response Rate in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma	3 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: 18 months

An adverse event (AE) is the development of an undesirable medical condition, or the deterioration of a pre-existing medical condition (other than the condition that is being treated by the trial) following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The number of participants experiencing such adverse events that are possibly/probably/definitely related to the study drugs are reported here.

Outcome measures

Outcome measures
Measure	Phase 1 n=5 Participants All patients in Phase I (this section contains the Maximum Tolerated Dose)	Dose Level -1 n=8 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 1 Sequential n=3 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 2 Sequential n=6 Participants Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle
Number of Participants Experiencing Adverse Events With the Combination of Pazopanib and Liposomal Doxorubicin Doses	5 Participants	7 Participants	2 Participants	6 Participants

Adverse Events

Dose Level 1

Serious events: 3 serious events

Other events: 5 other events

Deaths: 4 deaths

Dose Level -1

Serious events: 1 serious events

Other events: 8 other events

Deaths: 7 deaths

Dose Level 1 Sequential

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Level 2 Sequential

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 n=5 participants at risk Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level -1 n=8 participants at risk Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 1 Sequential n=3 participants at risk Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 2 Sequential n=6 participants at risk Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle
Investigations Alanine aminotransferase increased	20.0% 1/5	0.00% 0/8	0.00% 0/3	0.00% 0/6
Investigations Aspartate aminotransferase increased	20.0% 1/5	0.00% 0/8	0.00% 0/3	0.00% 0/6
Gastrointestinal disorders Abdominal pain	20.0% 1/5	0.00% 0/8	0.00% 0/3	0.00% 0/6
Metabolism and nutrition disorders Dehydration	20.0% 1/5	12.5% 1/8	0.00% 0/3	0.00% 0/6
Gastrointestinal disorders Pancreatitis	20.0% 1/5	0.00% 0/8	0.00% 0/3	0.00% 0/6
Musculoskeletal and connective tissue disorders Generalized muscle weakness	20.0% 1/5	0.00% 0/8	0.00% 0/3	0.00% 0/6
Infections and infestations Urinary tract infection	0.00% 0/5	12.5% 1/8	0.00% 0/3	0.00% 0/6
General disorders General disorders and administration site conditions - Other, disease progression	0.00% 0/5	12.5% 1/8	0.00% 0/3	0.00% 0/6
Infections and infestations Infections and infestations - Other, pneumonia	0.00% 0/5	0.00% 0/8	66.7% 2/3	0.00% 0/6
Cardiac disorders Atrial Fibrillation	0.00% 0/5	0.00% 0/8	33.3% 1/3	0.00% 0/6
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, COPD exacerbation	0.00% 0/5	0.00% 0/8	33.3% 1/3	0.00% 0/6
Injury, poisoning and procedural complications Fracture	0.00% 0/5	0.00% 0/8	0.00% 0/3	16.7% 1/6

Other adverse events

Other adverse events
Measure	Dose Level 1 n=5 participants at risk Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level -1 n=8 participants at risk Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 1 Sequential n=3 participants at risk Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle	Dose Level 2 Sequential n=6 participants at risk Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle
General disorders Fatigue	60.0% 3/5	50.0% 4/8	100.0% 3/3	50.0% 3/6
Gastrointestinal disorders Nausea	80.0% 4/5	37.5% 3/8	100.0% 3/3	33.3% 2/6
Gastrointestinal disorders Diarrhea	40.0% 2/5	37.5% 3/8	33.3% 1/3	33.3% 2/6
Investigations White blood cell decreased	40.0% 2/5	62.5% 5/8	33.3% 1/3	33.3% 2/6
Investigations Neutrophil count decreased	20.0% 1/5	37.5% 3/8	33.3% 1/3	50.0% 3/6
Blood and lymphatic system disorders Anemia	60.0% 3/5	25.0% 2/8	33.3% 1/3	50.0% 3/6
Investigations Platelet count decreased	0.00% 0/5	37.5% 3/8	33.3% 1/3	33.3% 2/6
Skin and subcutaneous tissue disorders Rash	60.0% 3/5	25.0% 2/8	100.0% 3/3	16.7% 1/6
Gastrointestinal disorders Mucositis	60.0% 3/5	25.0% 2/8	0.00% 0/3	50.0% 3/6
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	40.0% 2/5	25.0% 2/8	66.7% 2/3	16.7% 1/6
Gastrointestinal disorders Vomiting	20.0% 1/5	12.5% 1/8	66.7% 2/3	16.7% 1/6
Vascular disorders Hypertension	20.0% 1/5	12.5% 1/8	33.3% 1/3	16.7% 1/6
Metabolism and nutrition disorders Anorexia	40.0% 2/5	25.0% 2/8	0.00% 0/3	0.00% 0/6
Renal and urinary disorders Proteinuria	40.0% 2/5	0.00% 0/8	0.00% 0/3	16.7% 1/6
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/5	12.5% 1/8	33.3% 1/3	16.7% 1/6
Investigations Aspartate aminotransferase increased	20.0% 1/5	0.00% 0/8	33.3% 1/3	16.7% 1/6
Metabolism and nutrition disorders Hyperglycemia	20.0% 1/5	25.0% 2/8	0.00% 0/3	0.00% 0/6
General disorders General disorders and administration site conditions - Other, hemorrhage	0.00% 0/5	12.5% 1/8	33.3% 1/3	16.7% 1/6

Additional Information

John D. Hainsworth, MD

Sarah Cannon Research Institute

Phone: 1-877-691-7274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Publication restrictions are in place

Restriction type: OTHER