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

NCT ID: NCT01617928

Last Updated: 2017-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

veliparib (ABT-888)

Group Type: EXPERIMENTAL

veliparib (ABT-888)

Intervention Type: DRUG

Dosing orally twice daily starting Day 1 through day 7 of each cycle. Decisions to move to the next cohort will be based on evaluation of DLTs in the current cohort. Decisions will be made with a discussion between the Sponsor and the principal investigator to dose escalate or de-escalate or add more subjects to the cohort.

carboplatin

Intervention Type: DRUG

Carboplatin will be administered on Day 3 of each cycle, intravenously.

paclitaxel

Intervention Type: DRUG

Paclitaxel will be administered on Day 3 of each cycle, intravenously.

Interventions

veliparib (ABT-888)

Dosing orally twice daily starting Day 1 through day 7 of each cycle. Decisions to move to the next cohort will be based on evaluation of DLTs in the current cohort. Decisions will be made with a discussion between the Sponsor and the principal investigator to dose escalate or de-escalate or add more subjects to the cohort.

Intervention Type: DRUG

carboplatin

Carboplatin will be administered on Day 3 of each cycle, intravenously.

Intervention Type: DRUG

paclitaxel

Paclitaxel will be administered on Day 3 of each cycle, intravenously.

Intervention Type: DRUG

Other Intervention Names

paraplatin; taxol

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 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hideyuki Hashiba, BS

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 68622

Tokyo, , Japan

Countries

Japan

References

Mizugaki H, Yamamoto N, Nokihara H, Fujiwara Y, Horinouchi H, Kanda S, Kitazono S, Yagishita S, Xiong H, Qian J, Hashiba H, Shepherd SP, Giranda V, Tamura T. A phase 1 study evaluating the pharmacokinetics and preliminary efficacy of veliparib (ABT-888) in combination with carboplatin/paclitaxel in Japanese subjects with non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2015 Nov;76(5):1063-72. doi: 10.1007/s00280-015-2876-7. Epub 2015 Oct 3.

Reference Type: RESULT

PMID: 26433581 (View on PubMed)

Other Identifiers

M12-629

Identifier Type: -

Identifier Source: org_study_id