A Clinical Study Testing The Safety and Efficacy of CH5424802/RO5424802 in Patients With ALK Positive Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01588028 |
Recruitment Status
: Unknown
Verified October 2014 by Hoffmann-La Roche.
Recruitment status was: Active, not recruiting
First Posted
: April 30, 2012
Last Update Posted
: October 17, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
ALK-Rearranged Non-Small Cell Lung Cancer | Drug: CH5424802 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | September 2015 |
Estimated Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: phase 1
locally advanced or metastatic ALK-positive NSCLC patients who have failed crizotinib treatment
|
Drug: CH5424802
Oral capsules taken twice daily
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- Phase I: Dose limiting toxicity [ Time Frame: Phase I: April 2012 to September 2014 ]
- Phase I: Tumor regression effect, PK parameters [ Time Frame: Phase I: April 2012 to September 2014 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ECOG performance status =< 2
- Confirmed of ALK-positive NSCLC by FDA approved kit
- NSCLC that has failed crizotinib treatment for Phase I
- Measurable disease defined by RECIST 1.1
- Adequate hematologic, hepatic, renal function
Exclusion Criteria:
- Prior therapy with an ALK inhibitor other than crizotinib
- Brain metastases, which are symptomatic and/or requiring treatment
- History of serious cardiac dysfunction
- Clinically significant gastrointestinal abnormality that would affect the absorption of drug
- Pregnant or a lactating woman

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588028
United States, California | |
Orange, California, United States, 92868 | |
United States, Florida | |
Tampa, Florida, United States, 33612 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02114 | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
New York, New York, United States, 10065 | |
United States, Washington | |
Seattle, Washington, United States, 98104 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01588028 History of Changes |
Other Study ID Numbers: |
AF002JG NP28761 |
First Posted: | April 30, 2012 Key Record Dates |
Last Update Posted: | October 17, 2014 |
Last Verified: | October 2014 |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |