A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Randomized, Double Blind Study of Biomarkers Predictive of Improvement in Progression Free Survival in Patients With Advanced Pancreatic Cancer Treated With Tarceva.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674973
• Other study ID #: BO21129
• Secondary ID: 2007-003738-40
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2008
• Last updated: March 1, 2016
• Start date: June 2008
• Est. completion date: March 2015

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;

• measurable disease according to RECIST;

• failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;

• ECOG performance status of 0-2.

Exclusion Criteria:

• local or locally advanced-resectable pancreatic cancer;

• any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;

• major surgery within 2 weeks prior to randomization.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• erlotinib [Tarceva]
150mg po daily
• placebo
po daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Brazil,  Bulgaria,  Croatia,  Germany,  Hong Kong,  India,  Italy,  Latvia,  Lithuania,  Malaysia,  Mexico,  Peru,  Romania,  Russian Federation,  Singapore,  Slovenia,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EGFR expression and gene copy number, HER2, HER3 expression and k-RAS mutation status in tumor tissue, EGFR ligands in serum		At screening	No
Primary	Progression free survival		Event driven	No
Secondary	Response rate, disease control rate and overall survival		Event driven	No
Secondary	Adverse events, lab parameters		Throughout study	No