Trial Outcomes & Findings for Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer (NCT NCT01253369)

Last Updated: 2019-04-23

Results Overview

The 8-week progression free rate (PFR) was defined as achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).

Results posted on

2019-04-23

Participant Flow

Patients enrolled from November 2010 through April 2012.

Participant milestones

Participant milestones
Measure	Pazopanib Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
Overall Study STARTED	33
Overall Study Evaluable	30
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Pazopanib Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	2
Overall Study Death	1
Overall Study Progressive disease	23
Overall Study Not Evaluable	3

Baseline Characteristics

Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pazopanib n=33 Participants Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants
Response to 1st Line Therapy Chemo-Refractory	18 participants n=5 Participants
Response to 1st Line Therapy Chemo-Sensitive	15 participants n=5 Participants

PRIMARY outcome

Timeframe: For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).

Population: The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response.

Outcome measures

Outcome measures
Measure	Pazopanib n=30 Participants Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
8-Week Progression-Free Rate	0.567 proportion of patients Interval 0.434 to 0.692

SECONDARY outcome

Timeframe: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).

The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better objective response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Outcome measures

Outcome measures
Measure	Pazopanib n=30 Participants Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
Objective Response Rate	0.033 proportion of patients Interval 0.004 to 0.124

Adverse Events

Pazopanib

Serious events: 12 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pazopanib n=33 participants at risk Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
Cardiac disorders Cardiac disorders - Other, specify	12.1% 4/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Cardiac disorders Heart failure	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Cardiac disorders Ventricular arrhythmia	15.2% 5/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Nausea	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
General disorders Fatigue	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	9.1% 3/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Alanine aminotransferase increased	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Alkaline phosphatase increased	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Aspartate aminotransferase increased	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Lipase increased	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Metabolism and nutrition disorders Hypophosphatemia	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Musculoskeletal and connective tissue disorders Bone pain	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Nervous system disorders Memory impairment	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Renal and urinary disorders Proteinuria	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Vascular disorders Hypertension	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Vascular disorders Thromboembolic event	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.

Other adverse events

Other adverse events
Measure	Pazopanib n=33 participants at risk Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
Blood and lymphatic system disorders Anemia	9.1% 3/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	15.2% 5/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Cardiac disorders Cardiac disorders - Other, specify	18.2% 6/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Cardiac disorders Supraventricular tachycardia	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Endocrine disorders Endocrine disorders - Other, specify	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Endocrine disorders Hypothyroidism	9.1% 3/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Eye disorders Watering eyes	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Abdominal pain	12.1% 4/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Constipation	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Diarrhea	45.5% 15/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Dyspepsia	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Flatulence	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Mucositis oral	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Nausea	30.3% 10/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Pancreatitis	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Gastrointestinal disorders Vomiting	24.2% 8/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
General disorders Edema face	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
General disorders Fatigue	39.4% 13/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	24.2% 8/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Injury, poisoning and procedural complications Bruising	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Alanine aminotransferase increased	18.2% 6/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Alkaline phosphatase increased	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Aspartate aminotransferase increased	15.2% 5/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Blood bilirubin increased	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Investigations - Other, specify	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Neutrophil count decreased	12.1% 4/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Platelet count decreased	9.1% 3/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Serum amylase increased	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations Weight loss	15.2% 5/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Investigations White blood cell decreased	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Metabolism and nutrition disorders Anorexia	18.2% 6/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Metabolism and nutrition disorders Dehydration	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Metabolism and nutrition disorders Hypocalcemia	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Metabolism and nutrition disorders Hypokalemia	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Metabolism and nutrition disorders Hypomagnesemia	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Metabolism and nutrition disorders Hyponatremia	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Metabolism and nutrition disorders Hypophosphatemia	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Musculoskeletal and connective tissue disorders Pain in extremity	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Nervous system disorders Ataxia	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Nervous system disorders Depressed level of consciousness	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Nervous system disorders Dizziness	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Nervous system disorders Dysgeusia	15.2% 5/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Nervous system disorders Nervous system disorders - Other, specify	15.2% 5/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Psychiatric disorders Insomnia	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Renal and urinary disorders Proteinuria	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Respiratory, thoracic and mediastinal disorders Sinus disorder	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Skin and subcutaneous tissue disorders Dry skin	9.1% 3/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Skin and subcutaneous tissue disorders Pruritus	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Skin and subcutaneous tissue disorders Rash acneiform	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.0% 1/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	6.1% 2/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.
Vascular disorders Hypertension	24.2% 8/33 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4.

Additional Information

David Jackman, MD

Dana-Farber Cancer Institute

Phone: 617-632-6049

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place