A Randomized, Open Label, Phase II Proof of Concept Study of WX-671 in Combination With Gemcitabine vs.Gemcitabine Alone in Patients With Locally Advanced, Non Resectable Pancreatic Cancer in Order to Evaluate the Anti-Tumor Activity of the Combination Therapy
OBJECTIVES:
Primary
- Assess the antitumor activity of two different doses of anti-uPA serine protease
inhibitor WX-671 when given in combination with gemcitabine hydrochloride in patients
with locally advanced unresectable pancreatic cancer.
- Compare the efficacy, in terms of response rate, progression-free survival, time to
first metastasis, overall survival, and tumor and uPA system-related markers, of these
regimens in these patients.
- Compare the safety, in terms of vital signs, ECG, biochemistry, hematology (including
coagulation), and adverse events, of these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
of 3 treatment arms.
- Arm I: Patients receive of oral anti-uPA serine protease inhibitor WX-671 once daily in
weeks 1-8 (weeks 1-4 of each subsequent course) and gemcitabine hydrochloride IV over
30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1.
All subsequent courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.
- Arm II: Patients receive oral anti-uPA serine protease inhibitor WX-671 (at a lower
dose than in arm I) once daily in weeks 1-8 (weeks 1-4 of each subsequent course) and
gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of
each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in
weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy, in terms of response rate, progression-free survival, time to first metastasis, overall survival, and tumor and uPA system-related markers
3 years
No
Carola Mala, PhD
Study Chair
Wilex
Germany: Federal Institute for Drugs and Medical Devices
CDR0000553460
NCT00499265
April 2007
May 2010
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