A Clinical Study Testing The Safety and Efficacy of CH5424802/RO5424802 in Patients With ALK Positive Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
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

April 26, 2012
October 16, 2014
April 2012
September 2015   (final data collection date for primary outcome measure)
Phase I: Dose limiting toxicity [ Time Frame: Phase I: April 2012 to September 2014 ] [ Designated as safety issue: Yes ]
Phase I: Dose limiting toxicity, Phase II: Response Rate [ Time Frame: Phase I/II: April 2012 to September 2014 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01588028 on ClinicalTrials.gov Archive Site
Phase I: Tumor regression effect, PK parameters [ Time Frame: Phase I: April 2012 to September 2014 ] [ Designated as safety issue: Yes ]
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 ]
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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
ALK-Rearranged Non-Small Cell Lung Cancer
Drug: CH5424802
Oral capsules taken twice daily
Experimental: phase 1
locally advanced or metastatic ALK-positive NSCLC patients who have failed crizotinib treatment
Intervention: Drug: CH5424802
Gadgeel SM, Gandhi L, Riely GJ, Chiappori AA, West HL, Azada MC, Morcos PN, Lee RM, Garcia L, Yu L, Boisserie F, Di Laurenzio L, Golding S, Sato J, Yokoyama S, Tanaka T, Ou SH. Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol. 2014 Sep;15(10):1119-28. doi: 10.1016/S1470-2045(14)70362-6. Epub 2014 Aug 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
September 2015
September 2015   (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
  • 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 information is only displayed when the study is recruiting subjects
United States
 
NCT01588028
AF002JG, NP28761
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Not Provided
Hoffmann-La Roche
October 2014

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