Trial Outcomes & Findings for Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas (NCT NCT01730586)
NCT ID: NCT01730586
Last Updated: 2020-01-18
Results Overview
Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): \>20% increase (absolute increase \>5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) \[second tumor assessment not \<4 weeks from response observed\]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Assessed at 21 day cycle; Restaging done every 3 cycles
Results posted on
2020-01-18
Participant Flow
Recruitment Period: November 2012 to October 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Abraxane
Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Abraxane
Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
|
|---|---|
|
Overall Study
Progressive Disease
|
2
|
|
Overall Study
Inadequate Trial
|
8
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Hospice
|
1
|
Baseline Characteristics
Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
Baseline characteristics by cohort
| Measure |
Abraxane
n=34 Participants
Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Colorectal Cancer Diagnosis
Small Bowel Adenocarcinoma (SBA)
|
13 Participants
n=5 Participants
|
|
Colorectal Cancer Diagnosis
CIMP-high Colorectal Cancer (CRC)
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 21 day cycle; Restaging done every 3 cyclesPopulation: In the CIMP-CRC arm 15 participants were considered efficacy evaluable \[Of 21 treated, 6 participants were withdrawn due to toxicity (2) and due to clinical progression (4)\], and three were not evaluable in SBA arm.
Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): \>20% increase (absolute increase \>5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) \[second tumor assessment not \<4 weeks from response observed\]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.
Outcome measures
| Measure |
CIMP-high Colorectal Cancer
n=15 Participants
Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
|
Small Bowel Adenocarcinoma (SBA)
n=10 Participants
Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
|
|---|---|---|
|
Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)
Complete Response
|
0 Participants
|
0 Participants
|
|
Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)
Partial Response
|
0 Participants
|
2 Participants
|
|
Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)
Stable Disease
|
3 Participants
|
3 Participants
|
|
Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)
Progressive Disease
|
12 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Assessed at first cycle (21 days), up to 12 monthsPopulation: For progression-free survival, the intent-to-treat analysis performed using all available participants.
The length of time during and after the treatment a participant lives without disease progression. Time to progression functions estimated using the Kaplan-Meier method. Participants who drop out of the study included in the time to event data analysis as "censored data".
Outcome measures
| Measure |
CIMP-high Colorectal Cancer
n=21 Participants
Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
|
Small Bowel Adenocarcinoma (SBA)
n=13 Participants
Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
2.1 Months
Interval 1.7 to 2.5
|
3.2 Months
Interval 2.6 to 3.8
|
Adverse Events
Abraxane
Serious events: 20 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abraxane
n=34 participants at risk
Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
8.8%
3/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
17.6%
6/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Jejunal obstruction
|
2.9%
1/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Infections and infestations
Infection, Other - perirectal abcess
|
2.9%
1/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
2.9%
1/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
General disorders
Fever
|
2.9%
1/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Vascular disorders
Hypotension
|
5.9%
2/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Psychiatric disorders
Confusion
|
2.9%
1/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
Other adverse events
| Measure |
Abraxane
n=34 participants at risk
Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Abdominal distension
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
26.5%
9/34 • Number of events 18 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
4/34 • Number of events 4 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
20.6%
7/34 • Number of events 7 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
76.5%
26/34 • Number of events 26 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
35.3%
12/34 • Number of events 15 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
26.5%
9/34 • Number of events 10 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.3%
12/34 • Number of events 20 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
4/34 • Number of events 4 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
3/34 • Number of events 3 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
Blood bilirubin increased
|
8.8%
3/34 • Number of events 5 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Eye disorders
Blurred vision
|
11.8%
4/34 • Number of events 4 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.8%
4/34 • Number of events 6 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Nervous system disorders
Concentration impairment
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
23.5%
8/34 • Number of events 12 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
Creatinine increased
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
14.7%
5/34 • Number of events 6 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
29.4%
10/34 • Number of events 19 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
14.7%
5/34 • Number of events 6 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.7%
5/34 • Number of events 7 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
General disorders
Edema face
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
General disorders
Edema limbs
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Eye disorders
Eye disorders
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
General disorders
Fatigue
|
61.8%
21/34 • Number of events 39 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.8%
3/34 • Number of events 3 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
General disorders
Fever
|
14.7%
5/34 • Number of events 5 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
General disorders
Flu like symptoms
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Vascular disorders
Flushing
|
11.8%
4/34 • Number of events 9 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
General disorders
Gait disturbance
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.8%
3/34 • Number of events 3 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - (Other)
|
2.9%
1/34 • Number of events 3 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Gastroparesis
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Number of events 5 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Vascular disorders
Hematoma
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Vascular disorders
Hot flashes
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Vascular disorders
Hypertension
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.9%
1/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.8%
3/34 • Number of events 3 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.6%
7/34 • Number of events 7 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Vascular disorders
Hypotension
|
8.8%
3/34 • Number of events 4 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Endocrine disorders
Hypothyroidism
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Ileus
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Infections and infestations
Infections and infestations - (Other)
|
5.9%
2/34 • Number of events 4 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Psychiatric disorders
Insomnia
|
8.8%
3/34 • Number of events 5 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
Investigations - (Other)
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
General disorders
Localized edema
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Infections and infestations
Lung infection
|
8.8%
3/34 • Number of events 3 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
General disorders
Malaise
|
8.8%
3/34 • Number of events 4 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.9%
1/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
20.6%
7/34 • Number of events 8 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
41.2%
14/34 • Number of events 28 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
41.2%
14/34 • Number of events 24 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
Neutrophil count decreased
|
14.7%
5/34 • Number of events 6 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain
|
20.6%
7/34 • Number of events 12 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
2/34 • Number of events 4 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Nervous system disorders
Paresthesia
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.5%
9/34 • Number of events 9 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
Platelet count decreased
|
14.7%
5/34 • Number of events 8 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Nervous system disorders
Presyncope
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.8%
3/34 • Number of events 3 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.6%
6/34 • Number of events 6 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
2.9%
1/34 • Number of events 4 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - (Other)
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - (Other)
|
2.9%
1/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.9%
1/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Infections and infestations
Soft tissue infection
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
5.9%
2/34 • Number of events 2 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
8/34 • Number of events 12 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
Weight loss
|
14.7%
5/34 • Number of events 5 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
|
Investigations
White blood cell decreased
|
2.9%
1/34 • Number of events 1 • Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
|
Additional Information
Dr. Michael Overman, Associate Professor, GI Medical Oncology
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place