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A Phase I/II Study of ABT-888 in Combination With 5-fluorouracil and Oxaliplatin (Modified FOLFOX-6) in Patients With Metastatic Pancreatic Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic Pancreatic Cancer

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Trial Information

A Phase I/II Study of ABT-888 in Combination With 5-fluorouracil and Oxaliplatin (Modified FOLFOX-6) in Patients With Metastatic Pancreatic Cancer

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.

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 and INR < 2. Subjects on an anticoagulant must have a PTT 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicities

Outcome Description:

Adverse events will be graded according to NCICTAE version 4

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Michael Pishvaian, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Food and Drug Administration

Study ID:

LCCC 2009-608



Start Date:

February 2011

Completion Date:

December 2014

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Pancreas cancer
  • Veliparib
  • oxaliplatin
  • Pancreatic Neoplasms



Georgetown Lombardi Comprehensive Cancer CenterWashington, District of Columbia  20007