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

May 2, 2018 updated by: AbbVie
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hidaka-shi, Japan
        • Site Reference ID/Investigator# 128056
      • Hyogo, Japan
        • Site Reference ID/Investigator# 129976
      • Tokyo, Japan
        • Site Reference ID/Investigator# 128057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • ABT-888
  • veliparib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicities of veliparib
Time Frame: During the first cycle (28 days) of veliparib administration
During the first cycle (28 days) of veliparib administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participant physical exam measurements
Time Frame: Approximately 1 year
Blood pressure, pulse and body temperature
Approximately 1 year
Change in participant clinical lab results
Time Frame: Approximately 1 year
Hematology, Chemistry and Urinalysis
Approximately 1 year
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
Approximately 1 year
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
Participants will be followed for the duration of an expected average of 8 months.
Maximum observed plasma concentration (Cmax)
Time Frame: For 24 hours following veliparib dosing.
Maximum observed concentration, occurring at Tmax
For 24 hours following veliparib dosing.
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.
For 24 hours following veliparib dosing.
The area under the plasma concentration-time curve (AUC)
Time Frame: For 24 hours following veliparib dosing.
For 24 hours following veliparib dosing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: Hideyuki Hashiba, BS, AbbVie GK.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-489

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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