MedTrace Logo

A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma

NCT00558207 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-02-25

No results posted yet for this study

Summary

This is a multi-center, open-label randomized phase 2 study designed to assess the progression free survival (PFS) of patients with untreatment and unresectable pancreatic cancer following treatment with either ARQ 197 or gemcitabine. The study will also evaluate other efficacy and safety endpoints including overall response rate, overall survival and adverse events in the two treatment arms.

Conditions

  • Pancreatic Neoplasms

Interventions

DRUG

ARQ 197

120 mg capsule administered twice daily for 240 mg total daily dose

DRUG

gemcitabine

1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 4 weeks for the first 28 days (cycle). Each subsequent cycle will consist of 1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 3 weeks with no drug administered in the 4th week.

Sponsors & Collaborators

  • ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

    lead INDUSTRY

Principal Investigators

  • Cezary Szczylik, PhD · Klinika Onkologii WIM

  • Janusz Pawlega, PhD · Oddzial Kliniczny Kliniki Onkologii

  • Piotr Koralewski, MD · Oddzial Chemioterapii Krakow

  • Emilia Filipczyk-Cisarz, MD · Oddzial Chemioterapii Dolnoslaskie Centrum Onkologii

  • Ewa Kilar, MD · Regionalny Szpital Specjalistyczny Latawiec

  • Piotr Sawrycki, MD · Oddzial Onkologii Klinicznej im L Rydygiera

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00558207 on ClinicalTrials.gov