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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

This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01588028
First received: April 26, 2012
Last updated: June 6, 2013
Last verified: June 2013
History of Changes

April 26, 2012
June 6, 2013
April 2012
September 2014   (final data collection date for primary outcome measure)
Phase I: Dose limiting toxicity, Phase II: Response Rate [ Time Frame: Phase I/II: April 2012 to September 2014 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01588028 on ClinicalTrials.gov Archive Site
Phase I: Tumor regression effect, PK parameters, Phase II: Safety, Efficacy, PK parameters [ Time Frame: Phase I/II: April 2012 to September 2014 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Clinical Study Testing The Safety and Efficacy of CH5424802/RO5424802 in Patients With ALK Positive Non-Small Cell Lung Cancer
A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer

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.

In the Phase II portion, the efficacy of CH5424802 will be assessed at the recommended dose.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
ALK-Rearranged Non-Small Cell Lung Cancer
  • Drug: CH5424802
    Oral capsules taken twice daily
  • Drug: CH5424802
    Oral capsules taken twice daily at recommended dose determined in Phase I.
  • Experimental: phase 1
    locally advanced or metastatic ALK-positive NSCLC patients who have failed crizotinib treatment
    Intervention: Drug: CH5424802
  • Experimental: Phase II
    locally advanced or metastatic ALK-positive NSCLC patients who have failed crizotinib treatment
    Intervention: Drug: CH5424802
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
Not Provided
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ECOG performance status =< 2
  • Confirmed of ALK-positive NSCLC by FDA approved kit
  • NSCLC that has failed crizotinib treatment for Phase I and II A
  • 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
Both
18 Years and older
No
Contact: Reference Study ID Number: AF-002JG / NP28761 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States
 
NCT01588028
AF002JG, NP28761
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Chugai Pharmaceutical
Not Provided
Hoffmann-La Roche
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP