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

Roche

Status and phase

Completed

Phase 2

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Treatments

Drug: RO4929097

Study type

Interventional

Funder types

Industry

Identifiers

NCT01070927

NP22383

2008-006384-37

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 </= 4 weeks before first dose of study drug
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