A Clinical Study Testing The Safety and Efficacy of CH5424802 in Patients With ALK Positive Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified March 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01588028
First received: April 26, 2012
Last updated: March 27, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
In the Phase II portion, the efficacy of CH5424802 will be assessed at the recommended dose.
| Condition | Intervention | Phase |
|---|---|---|
|
ALK-Rearranged Non-Small Cell Lung Cancer |
Drug: CH5424802 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of the ALK Inhibitor CH5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Phase I: Dose limiting toxicity, Phase II: Response Rate [ Time Frame: Phase I/II: April 2012 to September 2014 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 94 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | September 2014 (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
|
|
Experimental: Phase II A
locally advanced or metastatic ALK-positive NSCLC patients who have failed crizotinib treatment
|
Drug: CH5424802
Oral capsules taken twice daily at recommended dose determined in Phase I.
|
|
Experimental: Phase II B
locally advanced or metastatic ALK-positive NSCLC patients who have never received ALK inhibitor treatment
|
Drug: CH5424802
Oral capsules taken twice daily at recommended dose determined in Phase I.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588028
Contacts
| Contact: Tomohiro Tanaka | clinical-trials@chugai-pharm.co.jp | |
| Contact: Linta Garcia | clinical-trials@chugai-pharm.co.jp |
Locations
| United States, California | |
| University of California Irvine Medical Center | Recruiting |
| Orange, California, United States | |
| Contact: Michele Azada, MPH, CCRP 714-456-8279 mazada@uci.edu | |
| Contact: Christina Siwak 714-456-8104 csiwak@uci.edu | |
| United States, Florida | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States | |
| Contact: Melissa Joiner 813-745-1896 melissa.joiner@moffitt.org | |
| United States, Massachusetts | |
| Dana-Faber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Peter Laub 617-582-8013 plaub@partners.org | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Marianela Oser 617-643-9909 MOSER2@PARTNERS.ORG | |
| United States, Michigan | |
| Karmanos Cancer Center | Recruiting |
| Detroit, Michigan, United States | |
| Contact: Deborah Hackstock 313-576-9454 hackstod@karmanos.org | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States | |
| Contact: Whitney Jappe 646-888-4358 JappeW@mskcc.org | |
| United States, Washington | |
| Swedish Cancer Institute | Recruiting |
| Seattle, Washington, United States | |
| Contact: Research Nurse 206-215-3086 | |
Sponsors and Collaborators
Hoffmann-La Roche
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01588028 History of Changes |
| Other Study ID Numbers: | NP28761 |
| Study First Received: | April 26, 2012 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013