NCT01617928
Completed
Phase 1
A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors
ConditionsSolid Tumors
Overview
- Phase
- Phase 1
- Intervention
- veliparib (ABT-888)
- Conditions
- Solid Tumors
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Determine the maximum tolerated dose and recommended Phase two dose
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) . Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in the subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have histologically or cytologically confirmed malignant solid tumor.
- •Patients who are amenable to standard combination chemotherapy of carboplatin and paclitaxel.
- •Patients should have received less than or equal to 1 prior chemotherapy regimens for advanced stage disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
- •Patients must have normal organ and marrow function
Exclusion Criteria
- •Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or the adverse events due to agents administered more than 3 weeks earlier have not recovered to less than grade
- •Known history of allergic reactions to carboplatin or cremophor-paclitaxel.
- •Patients who have previously received a poly(ADP-ribose) polymerase (PARP) inhibitor.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection requiring treatment, symptomatic congestive heart failure, angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •History of seizure disorder.
- •Hepatitis B surface antigen (HBsAg) positive, Hepatitis C virus (HCV) antibody positive or Human immunodeficiency virus (HIV)-positive patients.
Arms & Interventions
veliparib (ABT-888)
Intervention: veliparib (ABT-888)
veliparib (ABT-888)
Intervention: carboplatin
veliparib (ABT-888)
Intervention: paclitaxel
Outcomes
Primary Outcomes
Determine the maximum tolerated dose and recommended Phase two dose
Time Frame: During the first cycle (21 days from first dose of veliparib)
Secondary Outcomes
- Safety assessment; Adverse event monitoring(From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles))
- Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of carboplatin when administered in combination with veliparib (ABT-888) and paclitaxel(Six timepoints on Day 3 of first cycle (21 days))
- Safety assessment; Change from Baseline in Electrocardiogram (ECG)(Day 8 of first cycle (21 days))
- Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888)(Eight timepoints on Day 1 of first cycle (21 days))
- Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel(Eight timepoints on Day 3 of first cycle (21 days))
- Preliminary tumor response(From date of first dose of veliparib until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 6 cycles.)
- Safety assessment; Physical exam including vital signs(From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles))
- Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of paclitaxel when administered in combination with veliparib (ABT-888) and carboplatin(Eight timepoints on Day 3 of first cycle (21 days))
- Safety assessment; Clinical lab testings(From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles))
Study Sites (1)
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