A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors
An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination With Chemotherapy in Subjects With Solid Tumors
2 other identifiers
interventional
47
3 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 breast-cancer
Started Dec 2013
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 8, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 27, 2016
September 1, 2016
2.8 years
January 8, 2014
September 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with adverse events
Measured up to 30 days after the last dose of study drug.
Secondary Outcomes (7)
Objective Response Rate (ORR)
Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months.
Overall Survival (OS)
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)
Assessed at each visit up to 18 months after the last subject has enrolled in the study.
Progression Free Survival (PFS)
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
Up to 18 months.
- +2 more secondary outcomes
Study Arms (3)
Arm A - Veliparib Monotherapy
EXPERIMENTALSubjects in this arm will be dosed with Veliparib continuous dosing.
Arm B - Veliparib in Combination with Carboplatin & Paclitaxel
EXPERIMENTALSubjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy.
Arm C Veliparib in Combination with Modified FOLFIRI
EXPERIMENTALSubjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy.
Interventions
combination of Fluorouracil, leucovorin and irinotecan
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (5)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stacie Shepherd, PhD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2014
First Posted
January 13, 2014
Study Start
December 1, 2013
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
September 27, 2016
Record last verified: 2016-09