Trial Outcomes & Findings for ABT-888 and Temozolomide for Liver Cancer (NCT NCT01205828)

NCT ID: NCT01205828

Last Updated: 2025-02-12

Results Overview

complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2025-02-12

Participant Flow

Participant milestones

Measure	ABT-888 and Temozolomide ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ABT-888 and Temozolomide for Liver Cancer

Baseline characteristics by cohort

Measure	Temozolomide + ABT-888 n=16 Participants Temozolomide and ABT-888 temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	7 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria

Outcome measures

Measure	ABT-888 and Temozolomide n=16 Participants ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
Clinical Benefit Rate	3 participants

SECONDARY outcome

Timeframe: 2 years

the number of months between a patient's enrollment and his/her date of death

Outcome measures

Measure	ABT-888 and Temozolomide n=16 Participants ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
Overall Survival	13.1 months Interval 1.0 to 32.0

SECONDARY outcome

Timeframe: 2 years

The number of months between a patient's enrollment and his/her disease progression

Outcome measures

Measure	ABT-888 and Temozolomide n=16 Participants ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
Progression Free Survival	1.9 months Interval 1.8 to 2.0

SECONDARY outcome

Timeframe: 6 months

Population: grade 3 or 4 adverse events

Record of all toxicities graded according to the NCI CTCAE version 3.0

Outcome measures

Measure	ABT-888 and Temozolomide n=16 Participants ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
Number of Participants Who Had Grade 3 or 4 Adverse Events	5 participants

SECONDARY outcome

Timeframe: 6 months

Population: Since the treatment showed no significant efficacy against HCC, therefore study of biomarker that predict responsiveness of the treatment was not carried out.

To evaluate biological correlation with response to ABT-888 and temozolomide, including evaluation of loss of heterozygosity (LOH) of 13q, decreased expression of or mutations in BRCA-1 or -2, and a select assortment of DNA repair genes.

Outcome measures

Outcome data not reported

Adverse Events

Temozolomide + ABT-888

Serious events: 6 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Temozolomide + ABT-888 n=16 participants at risk Temozolomide and ABT-888 temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months).
Gastrointestinal disorders nausea, vomit	18.8% 3/16 • Number of events 4 • 6 months
General disorders fatigue	6.2% 1/16 • Number of events 1 • 6 months
Gastrointestinal disorders bleeding	6.2% 1/16 • Number of events 1 • 6 months
Renal and urinary disorders multiorgan failure	6.2% 1/16 • Number of events 1 • 6 months

Other adverse events

Measure	Temozolomide + ABT-888 n=16 participants at risk Temozolomide and ABT-888 temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months).
General disorders fatigue	43.8% 7/16 • Number of events 7 • 6 months
Blood and lymphatic system disorders platelet count decrease	37.5% 6/16 • Number of events 6 • 6 months
Blood and lymphatic system disorders low neutrophil	25.0% 4/16 • Number of events 4 • 6 months
Blood and lymphatic system disorders low lymphocyte	25.0% 4/16 • Number of events 4 • 6 months
Gastrointestinal disorders nausea, vomit	25.0% 4/16 • Number of events 4 • 6 months
Gastrointestinal disorders diarrhea	12.5% 2/16 • Number of events 2 • 6 months
Gastrointestinal disorders constipation	18.8% 3/16 • Number of events 3 • 6 months

Additional Information

Dr. Aiwu Ruth He

Georgetown University Medical Center

Phone: 202-444-8642

Email: arh29@georgetown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60