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

History of Changes

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: 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:

MedlinePlus related topics: Lung Cancer

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Phase I: Tumor regression effect, PK parameters [ Time Frame: Phase I: April 2012 to September 2014 ] [ Designated as safety issue: Yes ]


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
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
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 02215

Boston, Massachusetts, United States, 02114
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

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms	Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

ClinicalTrials.gov processed this record on March 03, 2015

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