ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Georgetown University
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
First received: December 8, 2011
Last updated: February 12, 2014
Last verified: February 2014

December 8, 2011
February 12, 2014
February 2011
December 2016   (final data collection date for primary outcome measure)
Dose limiting toxicities [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Adverse events will be graded according to NCICTAE version 4
Same as current
Complete list of historical versions of study NCT01489865 on ClinicalTrials.gov Archive Site
Objective Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete response + Partial response
Same as current
Not Provided
Not Provided
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

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.

Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Pancreatic Cancer
Drug: Veliparib and 5-FU and Oxaliplatin and Leucovorin
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
Other Names:
  • ABT-888
  • 5-Fluorouracil
  • Eloxatin
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
Intervention: Drug: Veliparib and 5-FU and Oxaliplatin and Leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proven pancreatic adenocarcinoma with measurable disease
  • ECOG performance status 0-2
  • Subjects with no brain metastases or a history of previously treated brain metastases who have been treated with surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of intercranial disease and have not had treatment with steroids within 1 week of study enrollment.
  • Subjects may have received any number of prior therapies except prior therapy with a PARP inhibitor
  • At least 14 days must have passed since all prior anti-cancer therapy
  • At least 28 days must have passed since any prior antibody-based therapies
  • At least 28 days must have passed since any prior investigational agent
  • All patients must have completely recovered from all transient side effects related to prior therapies and any side effects that are expected to be more durable or permanent must have resolved to Grade 1
  • Adequate hepatic, bone marrow and renal function
  • Partial thromboplastin time must be </= 2 X upper limit of institution's normal range and INR < 2. Subjects on an anticoagulant must have a PTT </= 5 X upper limit of institution's normal range and INR < 5.
  • Life expectancy > 12 weeks
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment
  • Subject must be capable of understanding and complying with parameters as outlined in protocol and able to sign and date the informed consent form
  • Patients must have fully recovered from all effects of surgery.

Exclusion Criteria:

  • Active severe infection, or known chronic infection with HIV, Hepatitis B virus or Hepatitis C virus
  • Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
  • Life-threatening visceral disease or other severe concurrent disease
  • Women who are pregnant or breast-feeding
  • Anticipated survival under 3 months
  • The subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder, or non-melanoma carcinoma of the skin.
  • Active uncontrolled infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris or cardiac arrhythmia
  • Psychiatric illness/ social situation that would limit compliance with study requirements
18 Years and older
Contact: Lisa Ley, RN MSN 202-687-6653 Leyl@georgetown.edu
Contact: Karen Dorsch-Vogel, RN 202-687-6974 kd252@georgetown.edu
United States
LCCC 2009-608
Georgetown University
Georgetown University
Principal Investigator: Michael Pishvaian, MD PhD Georgetown University
Georgetown University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP