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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01617928
First received: May 23, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Drug: veliparib (ABT-888)
Drug: carboplatin
Drug: paclitaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Determine the maximum tolerated dose and recommended Phase two dose [ Time Frame: During the first cycle (21 days from first dose of veliparib) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden

  • 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) ] [ Designated as safety issue: Yes ]
    Blood pressure, pulse and body temperature

  • 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) ] [ Designated as safety issue: Yes ]
    Hematology, Chemistry and Urinalysis

  • 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) ] [ Designated as safety issue: Yes ]
    Collect all adverse events at each visit

  • Safety assessment; Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Day 8 of first cycle (21 days) ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: veliparib (ABT-888) Drug: 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.
Drug: carboplatin
Carboplatin will be administered on Day 3 of each cycle, intravenously.
Other Name: paraplatin
Drug: paclitaxel
Paclitaxel will be administered on Day 3 of each cycle, intravenously.
Other Name: taxol

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617928

Locations
Japan
Site Reference ID/Investigator# 68622
Tokyo, Japan
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Hideyuki Hashiba, BS AbbVie GK
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01617928     History of Changes
Other Study ID Numbers: M12-629
Study First Received: May 23, 2012
Last Updated: July 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014