ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ArQule; ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
• Treatments: Beta-lapachone; Gemcitabine

Criteria

Inclusion Criteria:

• Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic adenocarcinoma

• Be treatment-naïve.

• Have measurable disease per RECIST Criteria.

• Be ≥18 years old.

• Have a Karnofsky Performance Status (KPS) of ≥70%.

• Have an estimated life expectancy of ≥12 weeks.

• Be male or a non-pregnant, non-lactating female patient. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy.

• Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).

• Sign a written informed consent form.

• Have adequate organ function as indicated by acceptable laboratory values obtained within 7 days prior to the first dose of study drug.

Exclusion Criteria:

• Have received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).

• Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.

• Are pregnant or lactating.

• Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.

• Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

• Have symptomatic or untreated central nervous system (CNS) metastases.

• Have a known hypersensitivity to gemcitabine.