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

Phase 2

Completed

• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Interventions: Drug: RO4929097

• Registration Number: NCT01070927
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cohort 1	RO4929097	-
cohort 2	RO4929097	-

Primary Outcome Measures

Name	Time	Method
Tumour blood flow and tumour metabolic response rate	PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile and pharmacodynamic parameters (e.g. changes in circulating endothelial and hematopoietic precursors)	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	assessments once every 2nd cycle on day 16
Safety and tolerability: AEs, laboratory parameters	throughout study, laboratory assessments on days 1, 8 and 15 of each cycle