Clinical trial NCT02033551: A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors
Official title: An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination With Chemotherapy in Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Ovarian Cancer
Colon Cancer
Lung Cancer
Gastric Cancer
Solid Tumors
Keywords: Gastric Cancer
Lung Cancer
PARP Inhibitor
Ovarian Cancer
Solid Tumors
Breast Cancer
Colon Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: Measured up to 30 days after the last dose of study drug.
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months.
measure: Overall Survival (OS)
timeFrame: 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.
measure: Time to Disease Progression (TTP)
timeFrame: Assessed at each visit up to 18 months after the last subject has enrolled in the study.
measure: Progression Free Survival (PFS)
timeFrame: 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.
measure: Clinical Laboratory Tests
timeFrame: Up to 18 months.
measure: Electrocardiogram
timeFrame: Up to 18 months.
measure: Tumor Assessment
timeFrame: Up to 18 months.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Site Reference ID/Investigator# 117416
state: Arizona
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 117415
state: Texas
city: Groningen
country: Netherlands
facility: Site Reference ID/Investigator# 117337
city: Maastricht
country: Netherlands
facility: Site Reference ID/Investigator# 117338
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 117451
Study officials:
affiliation: AbbVie
name: Stacie Shepherd, PhD
role: STUDY_DIRECTOR
References: