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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

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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
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
ALK-Rearranged Non-Small Cell Lung Cancer Drug: CH5424802 Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Alectinib
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Phase I: Dose limiting toxicity [ Time Frame: Phase I: April 2012 to September 2014 ]

Secondary Outcome Measures :
  1. Phase I: Tumor regression effect, PK parameters [ Time Frame: Phase I: April 2012 to September 2014 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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