Clinical trialPhase 1 / Phase 2Completed
ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer
A Phase I/II Study of ABT-888 in Combination With 5-fluorouracil and Oxaliplatin (Modified FOLFOX-6) in Patients With Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 3 January 2011
- Expected end
- 7 December 2023
- Enrollment
- 64 participants
- Sites
- 1
- Primary outcomes
- Phase 1: Number of Dose Limiting Toxicities; Phase II: Objective Response Rate (ORR)
- Sponsor
- Other
- Results posted
- 2025-11-06
- Last update
- 6 November 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase 1: Number of Dose Limiting Toxicities [28 days]. Number, Dose Limiting Toxicities. Phase 1: ABT-888 40mg (Cohort 1) (n=6): 3; Phase 1: ABT-888 60 mg (Cohort 2) (n=3): 0; Phase 1: ABT-888 80 mg (Cohort 3) (n=3): 0; Phase 1: ABT-888 100 mg (Cohort 4) (n=3): 0; Phase 1: ABT-888 150 mg (Cohort 5) (n=3): 0; Phase 1: ABT-888 200 mg (Cohort 6) (n=7): 0; Phase 1: ABT-888 250 mg (Cohort 7) (n=6): 4.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase II: Objective Response Rate (ORR) [6 months]. Count Of Participants, Participants. ABT-888 and mFOLFOX-6 Phase II (n=33): 4.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Control Rate (DCR) [6 months]. Count Of Participants, Participants. Phase 1: ABT-888 40mg (Cohort 1) (n=6): 1; Phase 1: ABT-888 60 mg (Cohort 2) (n=3): 0; Phase 1: ABT-888 80 mg (Cohort 3) (n=3): 0; Phase 1: ABT-888 100 mg (Cohort 4) (n=3): 0; Phase 1: ABT-888 150 mg (Cohort 5) (n=3): 1; Phase 1: ABT-888 200 mg (Cohort 6) (n=7): 1; Phase 1: ABT-888 250 mg (Cohort 7) (n=6): 0; Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg) (n=33): 5.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [up to 114 months]. Median, days (Full Range). Phase 1: ABT-888 40mg (Cohort 1) (n=6): 126.5 (65 to 509); Phase 1: ABT-888 60 mg (Cohort 2) (n=3): 49 (42 to 58); Phase 1: ABT-888 80 mg (Cohort 3) (n=3): 159 (91 to 948); Phase 1: ABT-888 100 mg (Cohort 4) (n=3): 77 (56 to 106); Phase 1: ABT-888 150 mg (Cohort 5) (n=3): 132 (37 to 671); Phase 1: ABT-888 200 mg (Cohort 6) (n=7): 148 (33 to 209); Phase 1: ABT-888 250 mg (Cohort 7) (n=6): 60.5 (49 to 122); Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg) (n=33): 102 (15 to 3431).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [up to 114 months]. Median, days (Full Range). Phase 1: ABT-888 40mg (Cohort 1) (n=6): 153 (89 to 750); Phase 1: ABT-888 60 mg (Cohort 2) (n=3): 89 (58 to 169); Phase 1: ABT-888 80 mg (Cohort 3) (n=3): 325 (159 to 948); Phase 1: ABT-888 100 mg (Cohort 4) (n=3): 294 (146 to 320); Phase 1: ABT-888 150 mg (Cohort 5) (n=3): 211 (37 to 671); Phase 1: ABT-888 200 mg (Cohort 6) (n=7): 176 (104 to 319); Phase 1: ABT-888 250 mg (Cohort 7) (n=6): 145.5 (49 to 336); Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg) (n=33): 260 (15 to 3431).