Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer (NCT NCT00454363)

Last Updated: 2020-04-03

Results Overview

RECIST Criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance 1/\> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Up to 18 months

Results posted on

2020-04-03

Participant Flow

Open recruitment period: March 2007 to December 2009. All recruitment done at University of Texas (UT) and Dana Farber Cancer Institute.

Of the 52 enrolled, one participant was excluded from the study prior to study treatment.

Participant milestones

Participant milestones
Measure	Pazopanib + Carcinoid Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.	Pazopanib + pNET Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
Overall Study STARTED	20	31
Overall Study COMPLETED	15	29
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pazopanib + Carcinoid Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.	Pazopanib + pNET Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
Overall Study Adverse Event	1	2
Overall Study Withdrawal prior to 12 weeks treatment	4	0

Baseline Characteristics

Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pazopanib + Carcinoid n=20 Participants Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.	Pazopanib + pNET n=31 Participants Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.	Total n=51 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	55 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	21 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	28 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	31 participants n=7 Participants	51 participants n=5 Participants
Participant from Enrolling Institutions Dana Farber Cancer Institute	6 participants n=5 Participants	11 participants n=7 Participants	17 participants n=5 Participants
Participant from Enrolling Institutions MD Anderson Cancer Center	14 participants n=5 Participants	20 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 18 months

Population: RECIST best protocol response by intention to treat. Four participants were not evaluable for response.

Outcome measures

Outcome measures
Measure	Pazopanib + Carcinoid n=20 Participants Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.	Pazopanib + pNET n=31 Participants Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) PR	0 participants	6 participants
Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) SD	14 participants	21 participants
Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) PD	3 participants	3 participants
Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Not Evaluable	3 participants	1 participants

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Data were not collected from any participant in the Pazopanib + Carcinoid Arm Group

Explore the effect on tumor blood flow as determined by functional CT of GW786034 (Pazopanib) 800 mg orally once daily on both arms, carcinoid and pNET.

Outcome measures

Outcome measures
Measure	Pazopanib + Carcinoid Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.	Pazopanib + pNET n=11 Participants Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
Percent Change in Tumor Blood Flow Assessed by Functional CT	—	139 percentage of change in tumor blood flow Interval -56.0 to 154.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 18 months.

Population: Analysis calculated according to intent to treat.

PFS is defined as the duration of time from start of treatment to time of progression or death.

Outcome measures

Outcome measures
Measure	Pazopanib + Carcinoid n=20 Participants Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.	Pazopanib + pNET n=31 Participants Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
Progression Free Survival (PFS)	12 months Interval 3.4 to 20.6	14.2 months Interval 6.9 to 21.5

OTHER_PRE_SPECIFIED outcome

Timeframe: assessed at Baseline and day 28, day 28 reported

Population: Plasma trough level in blood was below the level of detection.

Outcome measures

Outcome measures
Measure	Pazopanib + Carcinoid n=20 Participants Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.	Pazopanib + pNET n=31 Participants Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
Plasma Trough Level of GW786034	NA Participants Plasma trough level in blood was below the level of detection.	NA Participants Plasma trough level in blood was below the level of detection.

Adverse Events

Pazopanib

Serious events: 16 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pazopanib n=51 participants at risk Oral pazopanib hydrochloride once daily on days 1-28.
General disorders Death NOS	21.6% 11/51 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hyperglycemia	2.0% 1/51 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypertriglyceridemia	2.0% 1/51 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hyponatremia	2.0% 1/51 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Peripheral sensory neuropathy	2.0% 1/51 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Thromboembolic event	2.0% 1/51 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.

Other adverse events

Other adverse events
Measure	Pazopanib n=51 participants at risk Oral pazopanib hydrochloride once daily on days 1-28.
Gastrointestinal disorders Abdominal distension	3.9% 2/51 • Number of events 4 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Abdominal pain	70.6% 36/51 • Number of events 78 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Acidosis	3.9% 2/51 • Number of events 4 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Blood and lymphatic system disorders Activated partial thromboplastin time prolonged	9.8% 5/51 • Number of events 10 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Psychiatric disorders Agitation	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Alanine aminotransferase increased	37.3% 19/51 • Number of events 58 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Alkaline phosphatase increased	17.6% 9/51 • Number of events 28 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Immune system disorders Allergic rhinitis	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Alopecia	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Blood and lymphatic system disorders Anemia	45.1% 23/51 • Number of events 45 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Anorexia	23.5% 12/51 • Number of events 14 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Anxiety	7.8% 4/51 • Number of events 7 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 6/51 • Number of events 7 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Ascites	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Aspartate aminotransferase increased	52.9% 27/51 • Number of events 83 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Musculoskeletal and connective tissue disorders Back Pain	23.5% 12/51 • Number of events 15 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Renal and urinary disorders Bladder Spasm	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Blood bilirubin increased	33.3% 17/51 • Number of events 33 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Eye disorders Blurred vision	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Cardiac disorders Cardiac disorders	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Eye disorders Cataract	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Chest wall pain	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Chills	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Cholesterol high	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Cognitive disturbance	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Colitis	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Confusion	3.9% 2/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Constipation	29.4% 15/51 • Number of events 20 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Cough	13.7% 7/51 • Number of events 8 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Creatinine increased	9.8% 5/51 • Number of events 7 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Dehydration	3.9% 2/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Dental caries	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Depression	9.8% 5/51 • Number of events 6 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Diarrhea	80.4% 41/51 • Number of events 150 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Dizziness	21.6% 11/51 • Number of events 15 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Dry skin	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Dyspepsia	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Dyspnea	19.6% 10/51 • Number of events 11 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Edema, Face	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Edema, Limbs	15.7% 8/51 • Number of events 10 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.9% 2/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Reproductive system and breast disorders Erectile dysfunction	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Ear and labyrinth disorders External ear pain	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Eye disorders Eye infection/pain	3.9% 2/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Fatigue	84.3% 43/51 • Number of events 155 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Fecal incontinence	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Fever	19.6% 10/51 • Number of events 13 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Flatulence	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Flushing	13.7% 7/51 • Number of events 11 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Gastritis	27.5% 14/51 • Number of events 17 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Injury, poisoning and procedural complications Administration site issue	2.0% 1/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Headache	27.5% 14/51 • Number of events 26 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Ear and labyrinth disorders Hearing impaired	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Cardiac disorders Heart failure	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Hemorrhoidal hemorrhage	5.9% 3/51 • Number of events 6 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Endocrine disorders Hot flashes	5.9% 3/51 • Number of events 4 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypercalcemia	3.9% 2/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hyperglycemia	45.1% 23/51 • Number of events 73 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.8% 4/51 • Number of events 4 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hyperkalemia	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypernatremia	5.9% 3/51 • Number of events 5 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Cardiac disorders Hypertension	68.6% 35/51 • Number of events 45 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Endocrine disorders Hyperthyroidism	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypertriglyceridemia	3.9% 2/51 • Number of events 5 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypoalbuminemia	11.8% 6/51 • Number of events 8 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypocalcemia	19.6% 10/51 • Number of events 15 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypoglycemia	7.8% 4/51 • Number of events 11 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypokalemia	7.8% 4/51 • Number of events 8 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypomagnesemia	19.6% 10/51 • Number of events 15 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hyponatremia	11.8% 6/51 • Number of events 11 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Hypophosphatemia	13.7% 7/51 • Number of events 9 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Cardiac disorders Hypotension	3.9% 2/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Endocrine disorders Hypothyroidism	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Infections and infestations Infections	9.8% 5/51 • Number of events 5 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Blood and lymphatic system disorders INR increased	15.7% 8/51 • Number of events 16 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Insomnia	21.6% 11/51 • Number of events 12 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Investigations Investigations	3.9% 2/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Reproductive system and breast disorders Libido decreased	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Blood and lymphatic system disorders Lymphocyte count decreased	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Malabsorption	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Mucositis oral	19.6% 10/51 • Number of events 21 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Musculoskeletal and connective tissue disorders Muscle Weakness	7.8% 4/51 • Number of events 5 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Musculoskeletal and connective tissue disorders Muscle Weakness, Trunk	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Myalgia	5.9% 3/51 • Number of events 4 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Nail Loss	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Nausea	72.5% 37/51 • Number of events 104 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Nervous system disorders	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Neuralgia	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Blood and lymphatic system disorders Neutrophil count decreased	21.6% 11/51 • Number of events 29 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Non-cardiac chest pain	9.8% 5/51 • Number of events 6 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Oral pain	7.8% 4/51 • Number of events 4 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Musculoskeletal and connective tissue disorders Osteoporosis	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Pain	39.2% 20/51 • Number of events 24 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Musculoskeletal and connective tissue disorders Pain in extremity	13.7% 7/51 • Number of events 7 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia	5.9% 3/51 • Number of events 5 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Hepatobiliary disorders Pancreatitis	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Peripheral sensory neuropathy	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Blood and lymphatic system disorders Platelet count decreased	23.5% 12/51 • Number of events 19 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Metabolism and nutrition disorders Proteinuria	13.7% 7/51 • Number of events 9 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Pruritus	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Rash acneiform	7.8% 4/51 • Number of events 6 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Rectal hemorrhage	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Rectal pain	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Cardiac disorders Sinus bradycardia	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Sinusitis	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Skin disorders	15.7% 8/51 • Number of events 10 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Skin hypopigmentation	13.7% 7/51 • Number of events 7 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Skin infection	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Infections and infestations Soft tissue infection	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Stomach pain	2.0% 1/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Syncope	5.9% 3/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Ear and labyrinth disorders Tinnitus	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	5.9% 3/51 • Number of events 4 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Renal and urinary disorders Increased Urinary Frequency	11.8% 6/51 • Number of events 7 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Renal and urinary disorders Urinary Incontinence	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Renal and urinary disorders Urine Retention	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Renal and urinary disorders Urinary tract infection	3.9% 2/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Reproductive system and breast disorders Vaginal hemorrhage	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Reproductive system and breast disorders Vaginal infection	3.9% 2/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Cardiac disorders Vasovagal reaction	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Nervous system disorders Vertigo	2.0% 1/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Respiratory, thoracic and mediastinal disorders Voice alteration	2.0% 1/51 • Number of events 3 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Gastrointestinal disorders Vomiting	39.2% 20/51 • Number of events 37 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Weight gain	3.9% 2/51 • Number of events 2 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
General disorders Weight loss	15.7% 8/51 • Number of events 10 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Blood and lymphatic system disorders White blood cell decreased	19.6% 10/51 • Number of events 19 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.
Skin and subcutaneous tissue disorders Wound dehiscence	2.0% 1/51 • Number of events 1 • Adverse events occurring within 30 days of last dose investigational drug, with each cycle 28 days for up to 12 cycles. Overall participation period April 2007 to March 2013.

Additional Information

Dr. James Yao, MD/Professor, GI Medical Oncology, Study Principal Investigator

UT MD Anderson Cancer Center

Phone: 713-792-2828

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60