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A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors

Phase 1
20 Years
Open (Enrolling)
Solid Tumors

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Trial Information

A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed malignant solid tumor.

- Patients who are amenable to standard combination chemotherapy of carboplatin and

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose and recommended Phase two dose

Outcome Time Frame:

During the first cycle (21 days from first dose of veliparib)

Safety Issue:


Principal Investigator

Hideyuki Hashiba, BS

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie GK


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

May 2012

Completion Date:

June 2013

Related Keywords:

  • Solid Tumors
  • Neoplasms