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Completed

NCT Number: NCT01617928

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

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.

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Key information

Conditions

Solid Tumors

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 68622

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

carboplatin

Drug

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

Other names: paraplatin

paclitaxel

Drug

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

Other names: taxol

Primary outcomes

  1. 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

  1. Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888)

    Time frame: Eight timepoints on Day 1 of first cycle (21 days)

  2. 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

    Time frame: Eight timepoints on Day 3 of first cycle (21 days)

  3. 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

    Time frame: Eight timepoints on Day 3 of first cycle (21 days)

  4. 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

    Time frame: Six timepoints on Day 3 of first cycle (21 days)

  5. Preliminary tumor response

    Time frame: 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.

    Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden

  6. Safety assessment; Physical exam including vital signs

    Time frame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)

    Blood pressure, pulse and body temperature

  7. Safety assessment; Clinical lab testings

    Time frame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)

    Hematology, Chemistry and Urinalysis

  8. Safety assessment; Adverse event monitoring

    Time frame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)

    Collect all adverse events at each visit

  9. Safety assessment; Change from Baseline in Electrocardiogram (ECG)

    Time frame: Day 8 of first cycle (21 days)

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2012
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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