ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a single-arm, non-randomized study of ARQ 501 in combination with gemcitabine in adult patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma. The study objectives are: Primary Objective: Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination with gemcitabine. Secondary Objectives: 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

Official Title
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A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

Conditions
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Pancreatic Cancer, Adenocarcinoma

Intervention / Treatment
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* Drug: ARQ 501 in combination with gemcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARQ 501 in combination with gemcitabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document progression free survival after treatment with ARQ 501 and gemcitabine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document safety and efficacy of ARQ 501 in combination with gemcitabine |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, solid tumor, advanced solid tumor, pancreas, pancreatic cancer, cancer of the pancreas