Trial Outcomes & Findings for Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF (NCT NCT01367275)

Last Updated: 2020-09-03

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Enrollment (baseline) to disease progression or death, followed each 14 day treatment then every 2 months,up to 100 week

Results posted on

2020-09-03

Participant Flow

Recruitment Period: August 16, 2011 to September 7, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Early termination due to drug sponsor decision to no longer develop drug. One participant was enrolled but not eligible therefore not treated.

Participant milestones

Participant milestones
Measure	Brivanib + Irinotecan Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1. One cycle is 14 days.
Overall Study STARTED	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Brivanib + Irinotecan Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1. One cycle is 14 days.
Overall Study Ineligible	1
Overall Study Disease Progression	2

Baseline Characteristics

Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brivanib + Irinotecan n=8 Participants Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1. One cycle is 14 days.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment (baseline) to disease progression or death, followed each 14 day treatment then every 2 months,up to 100 week

Outcome measures

Outcome measures
Measure	Brivanib + Irinotecan n=8 Participants Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1. One cycle is 14 days.
Number of Participants With Median Progression-Free Survival (PFS)	7 Participants

Adverse Events

Brivanib + Irinotecan

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Brivanib + Irinotecan n=7 participants at risk Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1. One cycle is 14 days.
Gastrointestinal disorders Small intestinal obstruction	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.

Other adverse events

Other adverse events
Measure	Brivanib + Irinotecan n=7 participants at risk Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1. One cycle is 14 days.
Gastrointestinal disorders Abdominal pain	57.1% 4/7 • Number of events 5 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Anal pain	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Anorexia	42.9% 3/7 • Number of events 5 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Bloating	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
General disorders Chills	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Diarrhea	85.7% 6/7 • Number of events 15 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Nervous system disorders Dizziness	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Skin and subcutaneous tissue disorders Dry skin	28.6% 2/7 • Number of events 2 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Nervous system disorders Dysgeusia	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Dyspepsia	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
General disorders Edema limbs	42.9% 3/7 • Number of events 5 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
General disorders Fatigue	57.1% 4/7 • Number of events 6 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
General disorders Fever	42.9% 3/7 • Number of events 4 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Flatulence	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
General disorders Gait disturbance	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Mouth Sores, Gastrointestinal disorders	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
General disorders Fall, general soreness	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Vascular disorders Hypertension	57.1% 4/7 • Number of events 7 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Metabolism and nutrition disorders Hypoglycemia	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Metabolism and nutrition disorders Hypokalemia	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Metabolism and nutrition disorders Hypomagnesemia	28.6% 2/7 • Number of events 2 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Endocrine disorders Hypothyroidism	42.9% 3/7 • Number of events 5 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Infections and infestations Colitis	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
General disorders Malaise	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Mucositis oral	28.6% 2/7 • Number of events 3 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Nausea	85.7% 6/7 • Number of events 11 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Blood and lymphatic system disorders Neutrophil count decreased	28.6% 2/7 • Number of events 2 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Musculoskeletal and connective tissue disorders Pain (gluteal region)	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	28.6% 2/7 • Number of events 2 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Rectal fistula	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	28.6% 2/7 • Number of events 2 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Skin and subcutaneous tissue disorders Skin induration	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Small intestinal obstruction	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Nervous system disorders Syncope	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Vascular disorders Thromboembolic event	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Toothache	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Gastrointestinal disorders Vomiting	57.1% 4/7 • Number of events 7 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Investigations Weight loss	14.3% 1/7 • Number of events 8 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.
Investigations White blood cell decreased	14.3% 1/7 • Number of events 1 • Adverse Events were collected for each 14 day treatment cycle and following two weeks after the last treatment, for up to 72 weeks. One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.

Additional Information

Dr. Michael Overman, Associate Professor, GI Medical Oncology

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-2828

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place