Trial information
A Study of Tarceva (Erlotinib) in Patients With Pancreatic Cancer.
Status: No longer recruiting
Protocol number: ML19537
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: A study to evaluate the safety and effect on treatment response of Tarceva in patients with locally advanced, unresectable or metastatic pancreatic cancer
Brief summary: This study will provide access to Tarceva to patients with locally advanced, resectable or metastatic pancreatic cancer treated with standard of care chemotherapy (gemcitabine). All patients will receive Tarceva, 100mg/day orally, and efficacy and safety will be monitored throughout the trial. The anticipated time on study treatment is until disease progression, and the target sample size is < 100 individuals. Target sample size is
80.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Pancreatic Cancer
Intervention type: Drug
Intervention name: erlotinib[Tarceva]
Primary outcome: 1. Patient access.
Key secondary outcomes: 1. Safety: AEs, laboratory assessments; Efficacy: overall survival and progression-free survival; Quality of Life.
Inclusion criteria:
- adult patients, >=18 years of age;
- histologically or cytologically confirmed locally advanced, unresectable or metastatic pancreatic cancer;
- no prior systemic treatment for metastatic pancreatic cancer.
Exclusion criteria:
- prior therapy with HER1/EGFR inhibitors;
- unstable systemic disease;
- any other malignancies within 5 years.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2006
Trial registration date: 06/16/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Bari
- Bologna
- Catania
- Ferrara
- Napoli
- Pavia
- Perugia
- Pisa
- Pordenone
- Roma
- Verona
