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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedVeliparib and Carboplatin

Plus 2 other study approaches.

Who it may be forBreast Cancer · Ovarian Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 27, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: AbbVie
Interventions being studied: Drug: Veliparib; Drug: Carboplatin; Drug: Paclitaxel; Drug: FOLFIRI

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Site Reference ID/Investigator# 117416Scottsdale, Arizona
Site Reference ID/Investigator# 117415San Antonio, Texas
Site Reference ID/Investigator# 117337Groningen
Site Reference ID/Investigator# 117338Maastricht
Site Reference ID/Investigator# 117451Madrid

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 27, 2016. Always confirm current availability with the study team.

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