A Phase 2 Study of ARQ 501 in Combination with Gemcitabine in Adult Patients with Treatment Naive, Unresectable Pancreatic Adenocarcinoma

• Conditions: Treatment naive, unresectable pancreatic adenocarcinoma; MedDRA version: 8.1Level: LLTClassification code 10033611Term: Pancreatic carcinoma non-resectable

• Registration Number: EUCTR2006-001358-29-DE
• Lead Sponsor: ARQule Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Able to provide signed and dated informed consent prior to study-specific
screening procedures.
2. Have a pathologically confirmed diagnosis of unresectable pancreatic adenocarcinoma.
3. Measurable disease per RECIST.
4. greater or equal 18 years old.
5. Karnofsky Performance Status (KPS) of greater or equal 70%.
6. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of ARQ 501.
7. Hemoglobin (Hgb) greater or equal 10 g/dL.
8. Absolute neutrophil count (ANC) greater or equal 1.5 × 109/L (greater or equal 1,500/mm3).
9. Platelet count greater or equal 100 × 109/L (greater or equal 100,000/mm3).
10. Total bilirubin lower or equal 1.5 × upper limit of normal (ULN) or lower or equal 3.0 × ULN with metastatic liver disease.
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) lower or equal 2.5 × ULN or lower or equal 5.0 × ULN with metastatic liver disease.
12. Creatinine lower or equal 1.5 × ULN.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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. Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
3. Are pregnant or lactating.
4. Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
5. Symptomatic or untreated central nervous system (CNS) metastases.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified