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 18, 2013
Last verified: October 2013
  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:


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 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

  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

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 18, 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 July 26, 2014