A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors

AbbVie

Status and phase

Completed

Phase 1

Conditions

Solid Tumors

Treatments

Drug: carboplatin

Drug: veliparib (ABT-888)

Drug: paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01617928

M12-629

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

20 to 99 years old

Volunteers

No Healthy Volunteers

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 2.
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 2.
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.