Trial information
A Study of Pertuzumab in Combination With Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Status: No longer recruiting
Protocol number: WO20024
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to determine the maximum tolerated dose, and effect on tumor response, of a combination of pertuzumab and Tarceva in patients with locally advanced or metastatic non-small cell lung cancer after failure of previous chemotherapy
Brief summary: This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and Tarceva in patients with locally advanced or metastatic non-small cell lung cancer who have failed on at least one prior chemotherapy regimen. Pertuzumab will be administered as an intravenous infusion; a loading dose of 840mg will be administered on day 1, followed by a dose of 420mg every 3 weeks. Tarceva will be administered daily, at a dose level of 100mg po in a first cohort of patients escalated to a dose level of 150mg po in a second cohort. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals. Target sample size is
15.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: pertuzumab
Primary outcome: 1. Maximum tolerated dose; dose limiting toxicities.
Key secondary outcomes: 1. Efficacy: Tumor response (complete response, partial response). PK: Potential PK interaction between pertuzumab and erlotinib.
Inclusion criteria:
- adult patients, >=18 years of age;
- histological confirmation of non-small cell lung cancer;
- locally advanced or metastatic disease;
- failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease.
Exclusion criteria:
- prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study day -8;
- prior treatment with any agent which targets growth factors or their receptors;
- history of clinically significant cardiovascular disease;
- history or evidence of central nervous system metastases.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2006
Trial registration date: 08/16/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
Spain
United Kingdom
