CompletedNCT02033551Updated Sep 27, 2016

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

A Phase 1 interventional study of Veliparib and Carboplatin in Breast Cancer, Ovarian Cancer and Colon Cancer, sponsored by AbbVie. Completed at 5 sites in 3 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-09-27.

Sponsored by AbbVie · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 47
Allocation: Non-randomized
Ages: 18 Years to 99 Years
Sex: All

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.

Conditions studied

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

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Keywords

Gastric Cancer
Lung Cancer
PARP Inhibitor
Ovarian Cancer
Solid Tumors
Breast Cancer
Colon Cancer

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 726 are open to participants now.

This study's enrollment of 47 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 47 participants (actual)

Study arms

Experimental
Arm A - Veliparib Monotherapy
Subjects in this arm will be dosed with Veliparib continuous dosing.
Drug: Veliparib
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: Veliparib · Drug: Carboplatin · Drug: Paclitaxel
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 · Drug: FOLFIRI

Interventions

DrugVeliparib
Also known as: ABT-888
DrugCarboplatin
DrugPaclitaxel
Also known as: Taxol
DrugFOLFIRI
combination of Fluorouracil, leucovorin and irinotecan

What researchers measure

Primary outcomes

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

Secondary outcomes

Objective Response Rate (ORR)
Time frame: 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.
Time to Disease Progression (TTP)
Time frame: 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.
Clinical Laboratory Tests
Hematology, Chemistry, Urinalysis
Time frame: Up to 18 months.
Electrocardiogram
Time frame: Up to 18 months.
Tumor Assessment
A computerized tomography scan to document the size of the tumor.
Time frame: Up to 18 months.

Study locations

5 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02033551
Lead sponsor: AbbVie
Responsible party: Sponsor
First posted: Jan 13, 2014
Start date: Dec 2013
Primary completion: Sep 2016
Completion: Sep 2016
Last update: Sep 27, 2016

Study contacts

Stacie Shepherd, PhD

study director · AbbVie

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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