An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the anti-tumour activity, safety and tolerability of RO4929097 as monotherapy in patients with recurrent or refractory non-small cell lung cancer. Patients will receive oral doses of RO4929097 of 80mg (cohort 1) or recommended Phase II dose (cohort 2) on a 3 days on 4 days off schedule. Anticipated time on study treatment is until disease progression or unacceptable toxicity. Target sample size is <50.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: R04929097

Criteria

Inclusion Criteria:

• adult patients, >/= 18 years of age

• stage IIIB/IV recurrent or refractory non-small cell lung cancer

• at most 2 lines of prior therapy in the metastatic setting (first line: platinum containing regimen and bevacizumab; second line: EGFR-targeted therapy)

• ECOG performance status 0-2

• adequate liver, renal and bone marrow function

Exclusion Criteria:

• prior chemotherapy or radiotherapy
• history of other malignancy within the past 2 years, except for basal cell skin carcinoma or in situ cervical carcinoma

• history of CNS metastases or leptomeningeal metastases, except for clinically stable disease

• serious cardiovascular illness