A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open-label randomized phase 2 study designed to assess the progression free survival (PFS) of patients with untreatment and unresectable pancreatic cancer following treatment with either ARQ 197 or gemcitabine. The study will also evaluate other efficacy and safety endpoints including overall response rate, overall survival and adverse events in the two treatment arms.

• 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: Gemcitabine

Criteria

Inclusion Criteria:

1. Able to provide signed and dated informed consent prior to study-specific screening procedures

2. ≥ 18 years old

3. Histologically or cytologically confirmed locally advanced or metastatic unresectable pancreatic adenocarcinoma

4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

5. Karnofsky performance status (KPS) ≥ 70%

6. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment

7. Females of childbearing potential must have a negative serum pregnancy test

8. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with metastatic liver disease

9. Hemoglobin ≥ 10 g/dl

10. Total bilirubin ≤ 1.5 × ULN

11. Serum creatinine ≤ 1.5 x ULN

12. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L

13. Platelets ≥ 100 x 10^9/L

Exclusion Criteria:

1. 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)

2. Central nervous system metastases

3. Pregnant or breastfeeding

4. Significant gastrointestinal disorder, in the opinion of the Principal Investigator (e.g. Crohn's disease, ulcerative colitis, extensive gastric resection)

5. Unable or unwilling to swallow ARQ 197 capsules twice daily

6. Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin

7. Significant co-morbid conditions that in the opinion of the Investigator would impair study participation

8. Known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection