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

Hoffmann-La Roche7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

RO4929097DRUG

80mg po daily, 3 days on 4 days off schedule

RO4929097DRUG

recommended phaseII dose, orally once daily, 3 days on 4 days off schedule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Tumour blood flow and tumour metabolic response rate

Time frame: PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)

Secondary Outcomes

Pharmacokinetic profile and pharmacodynamic parameters (e.g. changes in circulating endothelial and hematopoietic precursors)

Time frame: pharmacokinetics: cycle 1 on days 1, 2, 4, 10, 11, 16; cycle 2 on days 1, 2, 16\npharmacodynamics: cycle 1 on days 1, 2, 4, 11, 16; cycle 2 on days 1, 16

Tumour response according to RECIST criteria

Time frame: assessments once every 2nd cycle on day 16

Safety and tolerability: AEs, laboratory parameters

Time frame: throughout study, laboratory assessments on days 1, 8 and 15 of each cycle

Data from ClinicalTrials.gov

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