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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00550004

Acronym

RP101

Enrollment

153

Registered

2007-10-26

Start date

2007-09-30

Completion date

2009-10-31

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Unresectable, locally advanced, metastatic pancreatic adenocarcinoma, Stage III, Stage IV

Brief summary

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).

Interventions

DRUGRP101

190 mg oral tablet

DRUGGemcitabine (1000 mg/m2)

30 minute intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall Survival	18 months

Secondary

Measure	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

Countries

Argentina, Brazil, Chile, France, Germany, Hungary, Netherlands, Peru, Poland, Romania, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026