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

May 23, 2012
July 9, 2013
May 2012
July 2013   (final data collection date for primary outcome measure)
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 ]
Determine the maximum tolerated dose and recommended Phase two dose [ Time Frame: From Day 1 to Day 21 of first cycle ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01617928 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ] [ 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 ] [ 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 ] [ 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 ] [ 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 ] [ 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 ] [ 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 ] [ 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors
A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
  • 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
Experimental: veliparib (ABT-888)
Interventions:
  • Drug: veliparib (ABT-888)
  • Drug: carboplatin
  • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01617928
M12-629
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Hideyuki Hashiba, BS AbbVie GK
AbbVie
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP