Trial Outcomes & Findings for Cabozantinib (XL-184) Monotherapy for Advanced Cholangiocarcinoma (NCT NCT01954745)
NCT ID: NCT01954745
Last Updated: 2017-02-03
Results Overview
To evaluate the median progression free survival (PFS) of cabozantinib in patients with advanced cholangiocarcinoma after progression on 1 or 2 prior systemic therapies.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
2 Years
Results posted on
2017-02-03
Participant Flow
Participant milestones
| Measure |
Cabozantinib
Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Cabozantinib
Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
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|---|---|
|
Overall Study
Radiological Progression
|
11
|
|
Overall Study
Clinical Progression
|
5
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Cabozantinib (XL-184) Monotherapy for Advanced Cholangiocarcinoma
Baseline characteristics by cohort
| Measure |
Cabozantinib
n=19 Participants
Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Gender
Female
|
13 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 YearsPopulation: Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles
To evaluate the median progression free survival (PFS) of cabozantinib in patients with advanced cholangiocarcinoma after progression on 1 or 2 prior systemic therapies.
Outcome measures
| Measure |
Cabozantinib
n=19 Participants
Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
1.8 months
Interval 1.6 to 5.4
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles
Evaluate the number of patients with advanced cholangiocarcinoma being treated with cabozantinib who have adverse events during treatment
Outcome measures
| Measure |
Cabozantinib
n=19 Participants
Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
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|---|---|
|
Number of Patients With Adverse Events
|
19 participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles
To evaluate the objective response rate (ORR) for patients with advanced cholangiocarcinoma receiving cabozantinib
Outcome measures
| Measure |
Cabozantinib
n=19 Participants
Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
|
|---|---|
|
Objective Response Rate (ORR)
|
0 percent
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles
To evaluate the median overall survival (OS) for patients with advanced cholangiocarcinoma receiving cabozantinib
Outcome measures
| Measure |
Cabozantinib
n=19 Participants
Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
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|---|---|
|
Median Overall Survival (OS)
|
5.2 months
Interval 2.7 to 10.5
|
Adverse Events
Cabozantinib
Serious events: 17 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cabozantinib
n=19 participants at risk
Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Elevated AST
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Elevated Serum ALKP
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Lipasemia
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
21.1%
4/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Dizziness
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Cardiac disorders
Hypertension
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Fatigue
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Mucositis
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Gastrointestinal Fistula
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
PPE
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Epistaxis
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
Other adverse events
| Measure |
Cabozantinib
n=19 participants at risk
Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
63.2%
12/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Leukopenia
|
57.9%
11/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Anemia
|
42.1%
8/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.6%
6/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Fatigue
|
84.2%
16/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Abdominal pain
|
63.2%
12/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Nausea
|
42.1%
8/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Metabolism and nutrition disorders
Anorexia
|
42.1%
8/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Diarrhea
|
36.8%
7/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Mucositis
|
31.6%
6/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Cardiac disorders
Hypertension
|
26.3%
5/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
36.8%
7/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Constipation
|
31.6%
6/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Vomiting
|
21.1%
4/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Asthenia
|
21.1%
4/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Dyspepsia/Heartburn
|
21.1%
4/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.1%
4/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Palmar Plantar Erythrodysesthesia
|
15.8%
3/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Abdominal distension
|
21.1%
4/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Pyrexia
|
15.8%
3/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
15.8%
3/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Metabolism and nutrition disorders
Weight Loss
|
15.8%
3/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Vascular disorders
Peripheral edema
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Foot pain
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Insomnia
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Hyperhidrosis
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Flatulence
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Gastrointestinal disorders
Cough
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Back Pain
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Psychiatric d/o
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Dizziness
|
5.3%
1/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
General disorders
Bleeding
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Elevated AST
|
63.2%
12/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Elevated ALKP
|
63.2%
12/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
68.4%
13/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Elevated ALT
|
57.9%
11/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
42.1%
8/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
36.8%
7/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
15.8%
3/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
21.1%
4/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
10.5%
2/19 • October 1, 2013 through February 12, 2015
The most common drug-related adverse events were fatigue, elevated AST, and thrombocytopenia. Serious adverse events included but were not limited to neutropenia, hyperbilirubinemia, epistaxis, bowel perforation, enterocutaneous fistula, and hypertension.
|
Additional Information
Dr. Lipika Goyal
Massachusetts General Hospital Cancer Center
Phone: 617-724-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place