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

NCT ID: NCT02033551

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-09-30

Brief Summary

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.

Conditions

Breast Cancer; Ovarian Cancer; Colon Cancer; Lung Cancer; Gastric Cancer; Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A - Veliparib Monotherapy

Subjects in this arm will be dosed with Veliparib continuous dosing.

Group Type: EXPERIMENTAL

Veliparib

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Veliparib

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Veliparib

Intervention Type: DRUG

FOLFIRI

Intervention Type: DRUG

combination of Fluorouracil, leucovorin and irinotecan

Interventions

Veliparib

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

FOLFIRI

combination of Fluorouracil, leucovorin and irinotecan

Intervention Type: DRUG

Other Intervention Names

ABT-888; Taxol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacie Shepherd, PhD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 117416

Scottsdale, Arizona, United States

Site Reference ID/Investigator# 117415

San Antonio, Texas, United States

Site Reference ID/Investigator# 117337

Groningen, , Netherlands

Site Reference ID/Investigator# 117338

Maastricht, , Netherlands

Site Reference ID/Investigator# 117451

Madrid, , Spain

Countries

United States; Netherlands; Spain

Other Identifiers

2013-003137-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M14-144

Identifier Type: -

Identifier Source: org_study_id