Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Placebo; Drug: dasatinib

• Registration Number: NCT01395017
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-15
• Primary Completion: 2013-10
• Results First Submitted: 2014-10-24
• Study Completion: 2015-03
• Results First Submitted QC: 2015-03-04
• Results First Posted: 2015-03-17
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• Histologic or cytologic documentation of unresectable adenocarcinoma of the pancreas.
• Recovery from toxicity of previous procedures to establish the diagnosis. ECOG PS 0 or 1.
• Adequate organ function.

Exclusion Criteria

• Evidence of metastatic disease.
• Previous radiotherapy or chemoradiotherapy.
• History of or current pleural effusion.
• History of significant cardiovascular disease.
• Clinically significant bleeding disorder or coagulopathy.
• Concomitant medication with strong CYP 3A4 inhibitor.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Placebo	The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).
Group 1	dasatinib	One arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus dasatinib 100 mg by mouth once daily (QD).

Primary Outcome Measures

Name	Time	Method
Overall Survival	From randomization until date of death from any cause by 02 December 2013	Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Time from randomization to earliest PFS event by 02 December 2013	PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.