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

NCT ID: NCT01070927

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cohort 1

Group Type EXPERIMENTAL

RO4929097

Intervention Type DRUG

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

cohort 2

Group Type EXPERIMENTAL

RO4929097

Intervention Type DRUG

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

Interventions

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RO4929097

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

Intervention Type DRUG

RO4929097

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2008-006384-37

Identifier Type: -

Identifier Source: secondary_id

NP22383

Identifier Type: -

Identifier Source: org_study_id