Trial Outcomes & Findings for A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC) (NCT NCT01490866)
NCT ID: NCT01490866
Last Updated: 2019-09-24
Results Overview
Defined as the time from first treatment until objective tumor progression or death from any cause, assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
24 months
Results posted on
2019-09-24
Participant Flow
Between January 2012 and January 2014, 70 patients with histologically or cytologically confirmed metastatic carcinoma of colon or rectum were enrolled and treated. The trial was conducted at 12 sites in the United States.
In this non-randomized open label trial, patients began treatment with FOLFOX/bevacizumab every 4 weeks for 16 weeks. Patients with objective response or stable disease began Axitinib maintenance therapy at week 17. Axitinib therapy continued until disease progression, unacceptable toxicity or did not meet any criteria for discontinuation.
Participant milestones
| Measure |
FOLFOX/Bevacizumab and Axitinib
All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
* 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
* Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
* Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
* Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
\- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs.
|
|---|---|
|
FOLFOX/Bevacizumab Treatment
STARTED
|
70
|
|
FOLFOX/Bevacizumab Treatment
COMPLETED
|
49
|
|
FOLFOX/Bevacizumab Treatment
NOT COMPLETED
|
21
|
|
Axitinib Maintenance Therapy
STARTED
|
49
|
|
Axitinib Maintenance Therapy
COMPLETED
|
0
|
|
Axitinib Maintenance Therapy
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
FOLFOX/Bevacizumab and Axitinib
All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
* 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
* Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
* Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
* Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
\- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs.
|
|---|---|
|
FOLFOX/Bevacizumab Treatment
Disease Progression
|
6
|
|
FOLFOX/Bevacizumab Treatment
Adverse Event
|
6
|
|
FOLFOX/Bevacizumab Treatment
Withdrawal by Subject
|
5
|
|
FOLFOX/Bevacizumab Treatment
Protocol Violation
|
1
|
|
FOLFOX/Bevacizumab Treatment
Intercurrent illness
|
1
|
|
FOLFOX/Bevacizumab Treatment
Physician Decision
|
2
|
|
Axitinib Maintenance Therapy
Disease Progression
|
30
|
|
Axitinib Maintenance Therapy
Adverse Event
|
12
|
|
Axitinib Maintenance Therapy
Withdrawal by Subject
|
3
|
|
Axitinib Maintenance Therapy
Protocol Violation
|
2
|
|
Axitinib Maintenance Therapy
Intercurrent illness
|
2
|
Baseline Characteristics
A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)
Baseline characteristics by cohort
| Measure |
FOLFOX/Bevacizumab and Axitinib
n=70 Participants
All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.
FOLFOX/bevacizumab:
* 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
* Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
* Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
* Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV
Maintenance:
\- Axitinib: 5-mg tablets orally twice per day (PO BID)
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
62 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: All patients who received at least one dose of any study drug.
Defined as the time from first treatment until objective tumor progression or death from any cause, assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
Outcome measures
| Measure |
FOLFOX/Bevacizumab and Axitinib
n=70 Participants
All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
* 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
* Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
* Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
* Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
\- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs.
|
Axitinib
All patients who received at least one dose of axitinib
|
|---|---|---|
|
Progression-free Survival
|
8.3 months
Interval 7.8 to 9.4
|
—
|
SECONDARY outcome
Timeframe: every 8 weeks, assessed up to approximately 24 monthsDefined as the percentage of evaluable patients showing a complete or partial response (CR or PR) per RECIST v1.1 criteria. CR = disappearance of all lesions. PR = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since start of treatment.
Outcome measures
| Measure |
FOLFOX/Bevacizumab and Axitinib
n=61 Participants
All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
* 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
* Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
* Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
* Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
\- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs.
|
Axitinib
All patients who received at least one dose of axitinib
|
|---|---|---|
|
Objective Response Rate
Objective Response
|
34 percentage of participants
|
—
|
|
Objective Response Rate
Stable Disease
|
57 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: every 8 weeks, assessed approximately up to 24 monthsDefined as the time after a disease is diagnosed (or treated) until worsening of the disease.
Outcome measures
| Measure |
FOLFOX/Bevacizumab and Axitinib
n=70 Participants
All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
* 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
* Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
* Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
* Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
\- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs.
|
Axitinib
All patients who received at least one dose of axitinib
|
|---|---|---|
|
Time To Progression (TTP)
|
8.8 months
Interval 8.1 to 10.2
|
—
|
SECONDARY outcome
Timeframe: every 8 weeks until progression then every 3 months for up to 5 years.Defined as the time from first treatment until death from any cause.
Outcome measures
| Measure |
FOLFOX/Bevacizumab and Axitinib
n=70 Participants
All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
* 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
* Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
* Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
* Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
\- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs.
|
Axitinib
All patients who received at least one dose of axitinib
|
|---|---|---|
|
Overall Survival (OS)
|
24.2 months
Interval 16.0 to 30.9
|
—
|
SECONDARY outcome
Timeframe: Every 4 weeks plus 30 days during treatment and up to 5 years thereafter.The frequency of adverse events (AEs) was analyzed in 2 groups of patients, those receiving FOLFOX/bevacizumab (N=70), and patients who received axitinib maintenance (N = 48). AEs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
Outcome measures
| Measure |
FOLFOX/Bevacizumab and Axitinib
n=70 Participants
All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
* 5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
* Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
* Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
* Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
\- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs.
|
Axitinib
n=49 Participants
All patients who received at least one dose of axitinib
|
|---|---|---|
|
Frequency of Adverse Events as a Measure of Safety
Vomiting
|
14 participants
|
0 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Hypertension
|
11 participants
|
22 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Fatigue
|
40 participants
|
24 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Nausea
|
37 participants
|
15 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Diarrhea
|
34 participants
|
16 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Peripheral neuropathy
|
34 participants
|
16 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Neutropenia
|
25 participants
|
0 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Thrombocytopenia
|
22 participants
|
8 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Leukopenia
|
21 participants
|
7 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Anorexia
|
19 participants
|
14 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Mucositis
|
18 participants
|
5 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Proteinuria
|
16 participants
|
12 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Anemia
|
16 participants
|
7 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Constipation
|
15 participants
|
0 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Pain
|
14 participants
|
11 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Headache
|
9 participants
|
7 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Myalgia
|
8 participants
|
10 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Dizziness
|
8 participants
|
0 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Skin changes
|
7 participants
|
0 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Arthralgia
|
7 participants
|
6 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Hand-foot skin reaction
|
0 participants
|
7 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Dyspnea
|
0 participants
|
7 participants
|
|
Frequency of Adverse Events as a Measure of Safety
Hoarseness
|
0 participants
|
7 participants
|
|
Frequency of Adverse Events as a Measure of Safety
AST increased
|
0 participants
|
5 participants
|
Adverse Events
FOLFOX/Bevacizumab and Axitinib
Serious events: 13 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOLFOX/Bevacizumab and Axitinib
n=70 participants at risk
|
|---|---|
|
General disorders
Chest pain
|
2.9%
2/70 • Number of events 2 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
2.9%
2/70 • Number of events 2 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
2/70 • Number of events 2 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/70 • Number of events 2 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
1/70 • Number of events 2 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/70 • Number of events 2 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Vascular disorders
Accelerated hypertension
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Asthenia
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Vascular disorders
Embolism
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Encephalopathy
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Enteritis
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Fatigue
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Investigations
International normalised ratio increased
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Pain
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Syncope
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Infections and infestations
Systemic candida
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Ureteric obstruction
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/70 • Number of events 1 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
Other adverse events
| Measure |
FOLFOX/Bevacizumab and Axitinib
n=70 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
12.9%
9/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
7.1%
5/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Investigations
Alkaline Phosphatase Increased
|
7.1%
5/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Immune system disorders
Allergic Reaction
|
8.6%
6/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
6/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Anemia
|
25.7%
18/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
34.3%
24/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
10/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.1%
5/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Asthenia
|
10.0%
7/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Chills
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Cold Intolerance
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
25.7%
18/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
7/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
40/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Dizziness
|
12.9%
9/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Dysesthesia
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
5/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
7/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.4%
8/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Edema
|
7.1%
5/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.6%
6/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Fatigue
|
68.6%
48/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
7.1%
5/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Headache
|
20.0%
14/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Hemorrhage
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.4%
8/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Vascular disorders
Hypertension
|
38.6%
27/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
7/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Endocrine disorders
Hypothyroidism
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Insomnia
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
35.7%
25/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Mucositis
|
25.7%
18/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.6%
13/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
55.7%
39/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
37.1%
26/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Oral Pain
|
10.0%
7/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
10.0%
7/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
14.3%
10/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Paresthesia
|
7.1%
5/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Peripheral Neuropathy
|
58.6%
41/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Proteinuria
|
28.6%
20/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
8/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Changes
|
14.3%
10/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Sore Throat
|
7.1%
5/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Nervous system disorders
Taste Alteration
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
General disorders
Temperature Intolerance
|
5.7%
4/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
35.7%
25/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
24.3%
17/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
|
Investigations
Weight Loss
|
10.0%
7/70 • Up to 3 years
Safety population included all patients who received at least one dose of any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER