ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01489865|
Recruitment Status : Unknown
Verified May 2019 by Georgetown University.
Recruitment status was: Active, not recruiting
First Posted : December 12, 2011
Last Update Posted : March 3, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Drug: ABT-888 and mFOLFOX-6||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of ABT-888 in Combination With 5-fluorouracil and Oxaliplatin (Modified FOLFOX-6) in Patients With Metastatic Pancreatic Cancer|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: ABT-888 and mFOLFOX-6
ABT-888 orally at escalating does in Phase I and then at recommended phase II dose with standard mFOLFOX-6
Drug: ABT-888 and mFOLFOX-6
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
- Dose limiting toxicities [ Time Frame: 28 days ]Adverse events will be graded according to NCICTAE version 4
- Objective Response [ Time Frame: 6 months ]Complete response + Partial response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489865
|United States, District of Columbia|
|Georgetown Lombardi Comprehensive Cancer Center|
|Washington, District of Columbia, United States, 20007|
|Study Chair:||Michael Pishvaian, MD PhD||M.D. Anderson Cancer Center|