Treatment naive, unresectable pancreatic adenocarcinoma MedDRA version: 8.1 Level: LLT Classification code 10033611 Term: Pancreatic carcinoma non-resectable
Conditions
Sponsors
ARQule Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination with gemcitabine;Secondary Objective: Determine time to tumor progression (TTP) of patients treated with ARQ 501 in combination with gemcitabine Further characterize the safety of ARQ 501 in combination with gemcitabine;Primary end point(s): The primary efficacy outcome measure is the overall response rate (ORR), defined as the proportion of patients with a documented complete or partial response (CR + PR). Assessment of clinical activity of ARQ 501 in combination with gemcitabine will be determined by the percentage of evaluable patients who exhibit a complete or partial response (i.e., CR + PR). The evaluable population is defined as patients who have been treated with at least 75 % of 2 complete cycles of ARQ 501 and gemcitabine. Ninety-five percent confidence intervals (CIs) will be calculated for the response rate. Tumor response will be characterized as the best overall response recorded from the time of first treatment. Best overall response will be determined using the RECIST response criteria described in Section 9.0 of this protocol. The number and percent of patients in each RECIST response category (CR, PR, SD, and PD) will also be summarized for the TTP patients. | — |
Countries
Germany
Outcome results
None listed