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

NCT01617928 | Completed Phase 1 DMC

• 1 other identifier: M12-629
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose and recommended Phase two dose

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

Secondary Outcomes (9)

• 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)

• 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)

• 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)

• 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.

Study Arms (1)

veliparib (ABT-888)

EXPERIMENTAL

Drug: veliparib (ABT-888); Drug: carboplatin; Drug: paclitaxel

Interventions

veliparib (ABT-888) 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.

veliparib (ABT-888)

carboplatin DRUG

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

Also known as: paraplatin

veliparib (ABT-888)

paclitaxel DRUG

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

Also known as: taxol

veliparib (ABT-888)

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (1)

Site Reference ID/Investigator# 68622

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 26433581 RESULT

MeSH Terms

Interventions

veliparib; Carboplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Hideyuki Hashiba, BS

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: June 13, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 20, 2017

Record last verified: 2013-07

Locations

JP (1)