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A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02210663
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: veliparib (ABT-888) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
Study Start Date : July 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: veliparib (ABT-888) Drug: veliparib (ABT-888)
Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.
Other Names:
  • veliparib
  • ABT-888




Primary Outcome Measures :
  1. Dose-limiting toxicities of veliparib [ Time Frame: During the first cycle (28 days) of veliparib administration ]

Secondary Outcome Measures :
  1. Change in participant physical exam measurements [ Time Frame: Approximately 1 year ]
    Blood pressure, pulse and body temperature

  2. Change in participant clinical lab results [ Time Frame: Approximately 1 year ]
    Hematology, Chemistry and Urinalysis

  3. Number of participants with adverse events [ Time Frame: Approximately 1 year ]
    Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03

  4. Preliminary tumor response [ Time Frame: Participants will be followed for the duration of an expected average of 8 months. ]
    According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

  5. Maximum observed plasma concentration (Cmax) [ Time Frame: For 24 hours following veliparib dosing. ]
    Maximum observed concentration, occurring at Tmax

  6. The time to Cmax (peak time, Tmax) [ Time Frame: For 24 hours following veliparib dosing. ]
    The time at which maximum plasma concentration (Cmax) is observed.

  7. The area under the plasma concentration-time curve (AUC) [ Time Frame: For 24 hours following veliparib dosing. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed malignant solid tumor, and any of the following: * Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; * Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; * Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy of greater than 12 weeks.
  • Adequate organ and marrow function· Measurable or non-measurable disease.

Exclusion Criteria:

  • Major surgery and/or radiation within (<) 4 weeks prior to study enrollment.
  • Chemotherapy or hormone therapy within (<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks.
  • Any investigational agents within (<) 4 weeks prior to study enrollment.
  • Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.
  • Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210663


Locations
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Japan
Site Reference ID/Investigator# 128056
Hidaka-shi, Japan
Site Reference ID/Investigator# 129976
Hyogo, Japan
Site Reference ID/Investigator# 128057
Tokyo, Japan
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Hideyuki Hashiba, BS AbbVie GK
Publications of Results:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02210663    
Other Study ID Numbers: M14-489
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: July 2016
Keywords provided by AbbVie:
Breast cancer
PARP
Primary peritoneal cancer
Fallopian tube
Ovarian cancer
veliparib
ABT-888
BRCA
Additional relevant MeSH terms:
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Neoplasms
Veliparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents