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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000081

Enrollment

200

Registered

2008-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Erlotinib: 150 mg po daily Control Intervention1: Placebo: po daily

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
EGFR expression and gene copy number, HER2, HER3 expression and k-RAS mutation status in tumor tissue, EGFR ligands in serumTimepoint: At screening;Progression free survivalTimepoint: Event driven	—

Secondary

Measure	Time frame
Adverse events, lab parametersTimepoint: Throughout study;Response rate, disease control rate and overall survivalTimepoint: Event driven	—

Countries

India

Contacts

Public ContactDr. Anil Kukreja

Medical Director

anil.kukreja@roche.com912224941414

Outcome results