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A Clinical Study Testing The Safety and Efficacy of CH5424802/RO5424802 in Patients With ALK Positive Non-Small Cell Lung Cancer
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by Hoffmann-La Roche.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01588028
First received: April 26, 2012
Last updated: October 16, 2014
Last verified: October 2014
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Purpose
CH5424802 is a newly invented, selective oral ALK inhibitor. In the Phase I portion, the goal is to determine the following: dose limiting toxicity, the maximum tolerated dose, pharmacokinetic (PK) parameters, and the recommended dose.
| Condition | Intervention | Phase |
|---|---|---|
| ALK-Rearranged Non-Small Cell Lung Cancer | Drug: CH5424802 | Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Alectinib
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Phase I: Dose limiting toxicity [ Time Frame: Phase I: April 2012 to September 2014 ]
Secondary Outcome Measures:
- Phase I: Tumor regression effect, PK parameters [ Time Frame: Phase I: April 2012 to September 2014 ]
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: phase 1
locally advanced or metastatic ALK-positive NSCLC patients who have failed crizotinib treatment
|
Drug: CH5424802
Oral capsules taken twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01588028
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588028
Locations
| 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 | |
Sponsors and Collaborators
Hoffmann-La Roche
More Information
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 |
| Study First Received: | April 26, 2012 |
| Last Updated: | October 16, 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 |
ClinicalTrials.gov processed this record on September 21, 2017