Trial Outcomes & Findings for A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer (NCT NCT01051596)
NCT ID: NCT01051596
Last Updated: 2019-04-02
Results Overview
Disease control rate defined as stable disease, partial response, or complete response according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
2 months
Results posted on
2019-04-02
Participant Flow
Participant milestones
| Measure |
ABT-888 and Temozolomide
Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle
Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle
ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer
Baseline characteristics by cohort
| Measure |
ABT-888 and Temozolomide
n=75 Participants
Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle
Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle
ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 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
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Percent of patients with disease control, according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Disease control rate defined as stable disease, partial response, or complete response according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
| Measure |
ABT-888 and Temozolomide
n=75 Participants
Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle
Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle
ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle
|
|---|---|
|
Percent of Patients With Disease Control
|
18 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All patients were evaluable for response, on an intention to treat basis
Progression-free survival defines as the time in days from study study entry until progression or death
Outcome measures
| Measure |
ABT-888 and Temozolomide
n=75 Participants
Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle
Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle
ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle
|
|---|---|
|
Median Progression-free Survival Time
|
1.8 Months
Interval 1.6 to 1.9
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All patients were evaluable for response, on an intention to treat basis
Overall survival defined as the time in days from study entry until death
Outcome measures
| Measure |
ABT-888 and Temozolomide
n=75 Participants
Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle
Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle
ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle
|
|---|---|
|
Overall Survival
|
6.6 Months
Interval 5.6 to 7.4
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: All patients were evaluable for response, on an intention to treat basis
Objective response rate defined as partial response or complete response according to RECIST criteria
Outcome measures
| Measure |
ABT-888 and Temozolomide
n=75 Participants
Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle
Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle
ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle
|
|---|---|
|
Percent of Patients With an Objective Response
|
2 Participants
|
Adverse Events
ABT-888 and Temozolomide
Serious events: 5 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-888 and Temozolomide
n=75 participants at risk
Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle
Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle
ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
1/75 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
4/75 • Number of events 4
|
Other adverse events
| Measure |
ABT-888 and Temozolomide
n=75 participants at risk
Temozolomide Days 1-5 and ABT-888 Days 1-7 of each 28-day cycle
Temozolomide: 150mg/m2 Days 1-5 of each 28 day cycle
ABT-888: 40mg orally BID Days 1-7 of each 28 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
53.3%
40/75
|
|
Blood and lymphatic system disorders
Anemia
|
46.7%
35/75
|
|
Blood and lymphatic system disorders
Leucopenia
|
20.0%
15/75
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.3%
13/75
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.7%
2/75
|
|
General disorders
Fatigue
|
25.3%
19/75
|
|
General disorders
Fever
|
2.7%
2/75
|
|
General disorders
Weight loss
|
1.3%
1/75
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.3%
1/75
|
|
Skin and subcutaneous tissue disorders
Peeling of feet
|
1.3%
1/75
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/75
|
|
Gastrointestinal disorders
Nausea
|
48.0%
36/75
|
|
Gastrointestinal disorders
Vomiting
|
18.7%
14/75
|
|
Gastrointestinal disorders
Anorexia
|
12.0%
9/75
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
5/75
|
|
Gastrointestinal disorders
Constipation
|
2.7%
2/75
|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/75
|
|
Gastrointestinal disorders
Dehydration
|
1.3%
1/75
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/75
|
|
Gastrointestinal disorders
Dysgeusia
|
1.3%
1/75
|
|
Blood and lymphatic system disorders
Urinary Hemorrhage
|
1.3%
1/75
|
|
Blood and lymphatic system disorders
Vaginal hemorrhage
|
1.3%
1/75
|
|
Blood and lymphatic system disorders
Petechiae/Purpura
|
1.3%
1/75
|
|
Infections and infestations
Febrile neutropenia
|
1.3%
1/75
|
|
Blood and lymphatic system disorders
Edema: limb
|
1.3%
1/75
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.3%
1/75
|
|
Metabolism and nutrition disorders
Elevated creatinine
|
1.3%
1/75
|
|
Nervous system disorders
Neuropathy: sensory
|
4.0%
3/75
|
|
Nervous system disorders
Dizziness
|
2.7%
2/75
|
|
General disorders
Pain NOS
|
4.0%
3/75
|
|
Nervous system disorders
Headache
|
1.3%
1/75
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
2.7%
2/75
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/75
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place