Trial information
A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
Status: Not yet recruiting
Protocol number: BO21129
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double blind study of biomarkers predictive of improvement in progression free survival in patients with advanced pancreatic cancer treated with Tarceva.
Brief 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. Target sample size is 200.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Pancreatic Cancer
Intervention type: Drug
Intervention name: erlotinib [Tarceva]
Primary outcome: 1. EGFR expression and gene copy number, HER2, HER3 expression and k-RAS mutation status in tumor tissue, EGFR ligands in serum Time frame: At screening
2. Progression free survival Time frame: Event driven
Key secondary outcomes: 1. Response rate, disease control rate and overall survival Time frame: Event driven
2. Adverse events, lab parameters Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2008
Trial registration date: 04/30/2008
Date last updated: 8/29/2008
Link to trial result
This trial will be conducted at the following locations:
Argentina
- Buenos Aires
- Rosario
- San Martín
- Santa Fe
- Villa Domínico
Australia
- Melbourne
- St. Leonards
- Sydney
Brazil
- Belo Horizonte
- Curitiba - Pr
- Ijuí
- Jaú
- Porto Alegre
- Porto Alegre - Rs
- Porto Alegre Rs
- Salvador
- Sao Paulo
Bulgaria
- Gabrovo
- Pleven
- Plovdiv
- Sofia
- Varna
- Vratza
China
Croatia
France
Germany
- Bochum
- Dresden
- Esslingen
- Frankfurt Am Main
- Greifswald
- Hamburg
- Köln
- Magdeburg
- Saarbruecken
- Ulm
India
- Bangalore
- Chennai
- Jaipur
- Kochi
- Kolkata
- Mumbai
- New Delhi
- Pune
- Vellore
Italy
- Bologna
- Ferrara
- Firenze
- Udine
Latvia
Lithuania
- Kaunas
- Vilnius
- Vilnius Lt
Malaysia
Mexico
Peru
- Arequipa
- Chiclayo
- Lima
- San Isidro
Romania
- Bucharest
- Cluj-Napoca
- Craiova (Dolj County)
- Iasi
Russian Federation
- Irkutsk
- Kazan
- Krasnodar
- Moscow
- St Petersburg
Singapore
Slovenia
Taiwan
Ukraine
United Kingdom
