Trial Outcomes & Findings for Genistein in Treatment of Metastatic Colorectal Cancer (NCT NCT01985763)
NCT ID: NCT01985763
Last Updated: 2019-05-10
Results Overview
Number of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle.
COMPLETED
PHASE1/PHASE2
13 participants
up to 6 months
2019-05-10
Participant Flow
Participant milestones
| Measure |
Genistein
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genistein in Treatment of Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
ECOG
0
|
8 Participants
n=5 Participants
|
|
ECOG
1
|
5 Participants
n=5 Participants
|
|
Tumor Location
Right Colon
|
3 Participants
n=5 Participants
|
|
Tumor Location
Left Colon
|
10 Participants
n=5 Participants
|
|
KRAS/NRAS
Wild Type (WT)
|
5 Participants
n=5 Participants
|
|
KRAS/NRAS
Mutated
|
6 Participants
n=5 Participants
|
|
KRAS/NRAS
Unknown
|
2 Participants
n=5 Participants
|
|
BRAF V600F
WT
|
11 Participants
n=5 Participants
|
|
BRAF V600F
Mutated
|
0 Participants
n=5 Participants
|
|
BRAF V600F
Unknown
|
2 Participants
n=5 Participants
|
|
Number of Metastatic Sites
1
|
8 Participants
n=5 Participants
|
|
Number of Metastatic Sites
2
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsNumber of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle.
Outcome measures
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Number of Adverse Events
Grade 1
|
250 events
|
|
Number of Adverse Events
Grade 2
|
119 events
|
|
Number of Adverse Events
Grade 3
|
24 events
|
|
Number of Adverse Events
Grade 4
|
0 events
|
PRIMARY outcome
Timeframe: end of Cycle 6Percent change in tumor size after cycle 6. Each cycle is 21 days.
Outcome measures
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Percent Change in Tumor Size
|
-43.0 Percent change
Interval -49.8 to -1.3
|
SECONDARY outcome
Timeframe: end of Cycle 6Response Rate (RR) as measured by radiologic RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Response Rate RECIST Criteria
PR
|
8 Participants
|
|
Response Rate RECIST Criteria
SD
|
1 Participants
|
|
Response Rate RECIST Criteria
PD
|
2 Participants
|
|
Response Rate RECIST Criteria
Not evaluable
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 50 monthsNumber of participants with an ORR - the portion of patients with a tumor size reduction of a predefined amount for a minimum time period
Outcome measures
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Number of Participants With an Overall Response Rate (ORR)
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 50 monthsBest Overall Response Rate (ORR) as measured by radiologic RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. SD - target lesion SD, non target lesions Non-PD, and no new lesions. PR - target lesion CR, non target lesions Incomplete response/SD and no new lesions; or target lesion PR, non target lesions Non-PD, and no new lesions. PD - target lesions PD, non target lesions Any, can have new lesions; or target lesions Any, non target lesions PD, can have new lesions; or target lesions Any, non target lesions Any, have new lesions.
Outcome measures
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Best Overall Response Rate RECIST Criteria
PR
|
6 Participants
|
|
Best Overall Response Rate RECIST Criteria
SD
|
3 Participants
|
|
Best Overall Response Rate RECIST Criteria
PD
|
2 Participants
|
|
Best Overall Response Rate RECIST Criteria
Not evaluable
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 50 monthsThe number of participants with best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Outcome measures
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Number of Participants With Best Overall Response Rate (ORR)
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 50 monthsPatients monitored for progression. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.
Outcome measures
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Progression Free Survival (PFS)
|
11.5 months
Interval 4.9 to 21.7
|
SECONDARY outcome
Timeframe: 6 month and 12 monthPatients monitored for progression during the study period and 1 year following. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.
Outcome measures
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months
6 months
|
69 percentage of participants
Interval 48.0 to 99.0
|
|
Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months
12 months
|
38 percentage of participants
Interval 19.0 to 76.0
|
SECONDARY outcome
Timeframe: up to 50 monthsOverall Survival - Number of months still living since baseline
Outcome measures
| Measure |
Genistein
n=13 Participants
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.
|
|---|---|
|
Overall Survival (OS)
|
36.5 months
Interval 29.5 to 50.0
|
Adverse Events
Genistein
Genistein and Chemotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Genistein
n=13 participants at risk
Genistein 60mg/day orally for 4 days before chemotherapy.
|
Genistein and Chemotherapy
n=13 participants at risk
Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to chemotherapy.
|
|---|---|---|
|
General disorders
Fatigue
|
15.4%
2/13 • Number of events 6 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
84.6%
11/13 • Number of events 55 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
General disorders
Hot Flashes
|
15.4%
2/13 • Number of events 8 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
7.7%
1/13 • Number of events 1 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
General disorders
Mucositis
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
38.5%
5/13 • Number of events 11 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Cardiac disorders
Hypertension
|
7.7%
1/13 • Number of events 2 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
92.3%
12/13 • Number of events 88 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
2/13 • Number of events 4 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
46.2%
6/13 • Number of events 23 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Number of events 10 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
61.5%
8/13 • Number of events 27 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
15.4%
2/13 • Number of events 9 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Blood and lymphatic system disorders
Bleeding
|
7.7%
1/13 • Number of events 1 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
46.2%
6/13 • Number of events 12 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
7.7%
1/13 • Number of events 1 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Blood and lymphatic system disorders
Thromboembolism
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
7.7%
1/13 • Number of events 1 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Nervous system disorders
Cold Sensitivity
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
92.3%
12/13 • Number of events 55 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • Number of events 11 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
7.7%
1/13 • Number of events 1 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Nervous system disorders
Neuropathy
|
15.4%
2/13 • Number of events 2 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
53.8%
7/13 • Number of events 34 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
7.7%
1/13 • Number of events 2 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
7.7%
1/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
61.5%
8/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
61.5%
8/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
1/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
61.5%
8/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
15.4%
2/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Infections and infestations
Fever
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
7.7%
1/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
61.5%
8/13 • 6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
|
Additional Information
Dr. Sofya Pintova
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place