People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.
This is a single arm, open-label Phase I/II study to evaluate the clinical activity of the novel inhibitor of Poly(ADP-ribose) polymerase (PARP), ABT-888 with modified FOLFOX-6 (5-Fluorouracil plus oxaliplatin) in patients with metastatic pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
ABT-888 in escalating doses twice a day for Days 1-7 of each 14-day cycle
Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Phase 1: Number of Dose Limiting Toxicities
Protocol defined events that are definitely, possibly or probably related to one or both agents and have occurred in the first cycle of therapy. Applies only to patients in the Phase I portion of the study.
Time frame: 28 days
Phase II: Objective Response Rate (ORR)
Number of Participants in Phase II with a Complete response and Partial response as determined by RECIST 1.1.
Time frame: 6 months
Disease Control Rate (DCR)
DCR is defined as the number of patients with a complete response, partial response, or stable disease at 6 months per Recist 1.1.
Time frame: 6 months
Progression Free Survival (PFS)
PFS is defined as the number of days from enrollment to progression or death, whichever occurred first.
Time frame: up to 114 months
Overall Survival
The number of days from enrollment until death or last contact. Patients who were alive at the time of analysis were censored at their last contact.
Time frame: up to 114 months
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