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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
combination of Fluorouracil, leucovorin and irinotecan
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
Number of subjects with adverse events
Time frame: Measured up to 30 days after the last dose of study drug.
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.
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Site Reference ID/Investigator# 117451
Madrid, Spain