NCT00558207View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

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.

Trial Locations (6)

31-531

Oddzial Kliniczny Kliniki Onkologii Szpital Uniwersytecki w Krakowie, Krakow

31-826

Oddzial Chemioterapii, Wojewodzki Szpital Specjalistyczny, Krakow

58-100

"Oddział Onkologii Klinicznej, Regionalny Szpital Specjalistyczny Latawiec", Swidnica

53/59

Oddział Onkologii Klinicznej SP ZOZ Wojewódzki Szpital Zespolony im. L. Rydygiera, Torun

00-909

Klinika Onkologii WIM Warszawa, Warsaw

53-413

Oddział Chemioterapii Dolnośląskie Centrum Onkologii, Wroclaw

All Listed Sponsors
lead

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

INDUSTRY

NCT00558207 - A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma | Biotech Hunter | Biotech Hunter