Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Vatalanib; Drug: Gemcitabine

• Registration Number: NCT00185588
• Lead Sponsor: George Albert Fisher

Brief Summary

The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2009-01
• Study Completion: 2009-12
• Results First Submitted: 2014-07-30
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-10
• Last Update Submitted: 2014-09-10
• Results First Posted: 2014-09-15
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 1 Dose Exploration 0 - Gemcitabine 700 + vatalanib 1250	Gemcitabine	Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Stage 1 Dose Explrtion2 - Gemcitabine850+vatalanib 2x250/2x500	Gemcitabine	Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Stage 1 Dose Exploration 1 - Gemcitabine 850 + vatalanib 1250	Gemcitabine	Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Stage 2 Dose Expansion - Gemcitabine850+vatalanib 2x250/2x500	Gemcitabine	Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Stage 1 Dose Exploration 0 - Gemcitabine 700 + vatalanib 1250	Vatalanib	Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Stage 2 Dose Expansion - Gemcitabine850+vatalanib 2x250/2x500	Vatalanib	Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Stage 1 Dose Exploration 1 - Gemcitabine 850 + vatalanib 1250	Vatalanib	Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Stage 1 Dose Explrtion2 - Gemcitabine850+vatalanib 2x250/2x500	Vatalanib	Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

Primary Outcome Measures

Name	Time	Method
Time-to-Treatment Failure (Intent-To-Treat Analysis)	12 months	For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death.; Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).

Secondary Outcome Measures

Name	Time	Method
Time-to-Progression, Evaluable Patients	12 months	Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States