Trial Outcomes & Findings for A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI (NCT NCT01322815)
NCT ID: NCT01322815
Last Updated: 2016-08-15
Results Overview
Clinical benefit rate is defined as the proportion of patients alive and free of progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients), assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target lesions; or SD (stable disease) = small changes that do not meet the above criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
4 Months for patients who had undergone prior 1st-line therapy, and 10 months for previously untreated patients
Results posted on
2016-08-15
Participant Flow
Participant milestones
| Measure |
Chemotherapy and GI-4000
Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
|
GI-4000 and Bevacizumab
maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI
Baseline characteristics by cohort
| Measure |
Chemotherapy and GI-4000
n=7 Participants
Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
|
GI-4000 and Bevacizumab
n=4 Participants
maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Continuous
|
48 years
n=93 Participants
|
45 years
n=4 Participants
|
45 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
4 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Prior treatment status
Prior 1st-line therapy
|
0 participants
n=93 Participants
|
4 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Prior treatment status
No prior therapy
|
7 participants
n=93 Participants
|
0 participants
n=4 Participants
|
7 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 Months for patients who had undergone prior 1st-line therapy, and 10 months for previously untreated patientsPopulation: Patients with RAS mutant positive metastatic colorectal cancer (CRC), either newly diagnosed, or having completed first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen.
Clinical benefit rate is defined as the proportion of patients alive and free of progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients), assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target lesions; or SD (stable disease) = small changes that do not meet the above criteria.
Outcome measures
| Measure |
Chemotherapy and GI-4000
n=7 Participants
Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
|
GI-4000 and Bevacizumab
n=4 Participants
maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks
|
|---|---|---|
|
Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)
|
4 participants
|
2 participants
|
Adverse Events
Chemotherapy and GI-4000
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
GI-4000 and Bevacizumab
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy and GI-4000
n=7 participants at risk
Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
|
GI-4000 and Bevacizumab
n=4 participants at risk
maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks
|
|---|---|---|
|
Cardiac disorders
thrombosis
|
14.3%
1/7 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
0.00%
0/4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
Blood and lymphatic system disorders
low neutrophil count
|
14.3%
1/7 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
0.00%
0/4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
Other adverse events
| Measure |
Chemotherapy and GI-4000
n=7 participants at risk
Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
|
GI-4000 and Bevacizumab
n=4 participants at risk
maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
42.9%
3/7 • Number of events 4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
0.00%
0/4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
0.00%
0/4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
Gastrointestinal disorders
diarrhea
|
57.1%
4/7 • Number of events 5 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
0.00%
0/4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
Respiratory, thoracic and mediastinal disorders
Epitaxis
|
57.1%
4/7 • Number of events 5 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
25.0%
1/4 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
General disorders
Fatigue
|
57.1%
4/7 • Number of events 5 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
25.0%
1/4 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
General disorders
flu
|
14.3%
1/7 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
0.00%
0/4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
Nervous system disorders
headache
|
14.3%
1/7 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
25.0%
1/4 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
Cardiac disorders
hypertension
|
14.3%
1/7 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
0.00%
0/4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
14.3%
1/7 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
75.0%
3/4 • Number of events 3 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
Gastrointestinal disorders
nausea
|
42.9%
3/7 • Number of events 3 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
25.0%
1/4 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
Skin and subcutaneous tissue disorders
rash
|
42.9%
3/7 • Number of events 4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
0.00%
0/4 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
|
General disorders
Vaginismus
|
0.00%
0/7 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
25.0%
1/4 • Number of events 1 • From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place