Phase II Study To Evaluate Efficacy And Safety Of RP101 In Combination With Gemcitabine

Study Overview

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

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).

N/A

Pancreatic Cancer

DRUG: RP101
DRUG: Gemcitabine (1000 mg/m2)

SCI-RP-Pan-P2-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-10-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-06-06
First Submitted that Met QC Criteria 2007-10-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-06-08
First Posted (ESTIMATED) 2007-10-26	Results First Posted N/A	Last Verified 2009-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Health Services Research

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Arm 1 RP101 and Gemcitabine	DRUG: RP101 190 mg oral tablet DRUG: Gemcitabine (1000 mg/m2) 30 minute intravenous infusion
PLACEBO_COMPARATOR: Arm 2 Placebo and Gemcitabine	DRUG: Gemcitabine (1000 mg/m2) 30 minute intravenous infusion

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Arm 1

RP101 and Gemcitabine

DRUG: RP101

190 mg oral tablet

DRUG: Gemcitabine (1000 mg/m2)

30 minute intravenous infusion

PLACEBO_COMPARATOR: Arm 2

Placebo and Gemcitabine

DRUG: Gemcitabine (1000 mg/m2)

30 minute intravenous infusion

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival		18 months

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Manuel Hidalgo, MD, PhD, Centro Integral de Oncologia

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Heinrich JC, Tuukkanen A, Schroeder M, Fahrig T, Fahrig R. RP101 (brivudine) binds to heat shock protein HSP27 (HSPB1) and enhances survival in animals and pancreatic cancer patients. J Cancer Res Clin Oncol. 2011 Sep;137(9):1349-61. doi: 10.1007/s00432-011-1005-1. Epub 2011 Jul 22.

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Clinical Trial Record