Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine

Study Overview
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Brief Summary
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This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).

Official Title
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Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: RP101
* Drug: Gemcitabine (1000 mg/m2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be 18 years of age or older Not previously treated with chemotherapy for Pancreatic Cancer ECOG performance status of 0 or 1 Life expectancy > 3 months Documentation of all sites of pancreatic disease within 28 days prior to randomization Adequate hematological, renal, and hepatic function Not pregnant or nursing Fertile subjects must practice a medically approved method of contraception Exclusion Criteria: Prior history of other malignant tumors Participation in another investigational study within 4 weeks prior to treatment start Major surgery within 14 days prior to treatment start Radiation treatment within 28 days prior to treatment start Uncontrolled cardiac atrial or ventricular arrhythmias Gastrointestinal tract disease such resulting in an inability to take oral medication Known to be seropositive for HIV, HBV, or HCV Uncontrolled cancer pain

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>RP101 and Gemcitabine | Drug: RP101<br>* 190 mg oral tablet<br>Drug: Gemcitabine (1000 mg/m2)<br>* 30 minute intravenous infusion<br>* Other names: Gemzar;|
| Placebo Comparator: Arm 2<br>Placebo and Gemcitabine | Drug: Gemcitabine (1000 mg/m2)<br>* 30 minute intravenous infusion<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 14 months | 
| Evaluate the CA 19-9 levels |  | 12 months | 
| Compare changes in ECOG |  | 12 months | 
| Evaluate Safety of RP101 |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable, locally advanced, metastatic pancreatic adenocarcinoma, Stage III, Stage IV