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

Pancreatic Cancer Clinical Trial

— LAPC  

Official title:

Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395017
• Other study ID #: 287-11-201
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2011
• Last updated: January 28, 2016
• Start date: June 2011
• Est. completion date: March 2015

Study information

• Verified date: January 2016
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• dasatinib
GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
• Placebo
Matching Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Ireland,  Italy,  Poland,  Romania,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.	From randomization until date of death from any cause by 02 December 2013	No
Secondary	Progression Free Survival (PFS)	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.	Time from randomization to earliest PFS event by 02 December 2013	No