A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors

September 26, 2016 updated by: AbbVie

An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination With Chemotherapy in Subjects With Solid Tumors

This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

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

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Site Reference ID/Investigator# 117337
      • Maastricht, Netherlands, 6229 HX
        • Site Reference ID/Investigator# 117338
  • Spain
      • Madrid, Spain, 28050
        • Site Reference ID/Investigator# 117451
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Site Reference ID/Investigator# 117416
    • Texas
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 117415

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have confirmed solid malignancy that is metastatic, and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
  • For Veliparib monotherapy (must have tumor with defects in DNA repair mechanisms (BRCA mutation or high grade ovarian cancer or solid tumors for combination therapy.
  • If the subject has known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of Central Nervous System (CNS) disease progression as determined by comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids (must have discontinued steroids at least 3 months prior to study drug administration).
  • Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.

Exclusion Criteria:

  • Subject has a clinically significant and uncontrolled major medical condition(s) including but not limited to:
  • Uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months;
  • Uncontrolled nausea/vomiting/diarrhea;
  • Active uncontrolled infection;
  • Symptomatic congestive heart failure;
  • Unstable angina pectoris or cardiac arrhythmia;
  • Psychiatric illness/social situation that would limit compliance with study requirements;
  • Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
  • Subjects who have hypersensitivity to Carboplatin, Paclitaxel or Cremophor should be excluded from arm B.
  • Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug or a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
  • Subject who requires parenteral nutrition, tube feeding or has evidence of a partial bowel obstruction or perforation within 28 days prior to study drug.
  • The subject has had another active malignancy within the past 3 years except for any cancer in situ that the Principal Investigator considers to be cured.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A - Veliparib Monotherapy
Subjects in this arm will be dosed with Veliparib continuous dosing.
Drug: Veliparib
Other Names:
  • ABT-888
Experimental: Arm B - Veliparib in Combination with Carboplatin & Paclitaxel
Subjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy.
Drug: Carboplatin
Drug: Paclitaxel
Other Names:
  • Taxol
Drug: Veliparib
Other Names:
  • ABT-888
Experimental: Arm C Veliparib in Combination with Modified FOLFIRI
Subjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy.
Drug: Veliparib
Other Names:
  • ABT-888
Drug: FOLFIRI
combination of Fluorouracil, leucovorin and irinotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with adverse events
Time Frame: Measured up to 30 days after the last dose of study drug.
Measured up to 30 days after the last dose of study drug.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months.
Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months.
Overall Survival (OS)
Time Frame: Every 3 months after the subject is registered off study up to 2 years post discontinuation or until date of death from any cause, whichever comes first.
Every 3 months after the subject is registered off study up to 2 years post discontinuation or until date of death from any cause, whichever comes first.
Time to Disease Progression (TTP)
Time Frame: Assessed at each visit up to 18 months after the last subject has enrolled in the study.
Assessed at each visit up to 18 months after the last subject has enrolled in the study.
Progression Free Survival (PFS)
Time Frame: Radiographic evaluation starting from the first day of study drug until documented progression or date of death, whichever comes first, until the subject is registered off study.
Radiographic evaluation starting from the first day of study drug until documented progression or date of death, whichever comes first, until the subject is registered off study.
Clinical Laboratory Tests
Time Frame: Up to 18 months.
Hematology, Chemistry, Urinalysis
Up to 18 months.
Electrocardiogram
Time Frame: Up to 18 months.
Up to 18 months.
Tumor Assessment
Time Frame: Up to 18 months.
A computerized tomography scan to document the size of the tumor.
Up to 18 months.

Collaborators and Investigators

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

Sponsor

AbbVie

Investigators

  • Study Director: Stacie Shepherd, PhD, AbbVie

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

December 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-144
  • 2013-003137-16 (EudraCT Number)

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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