Status:
TERMINATED
A Study of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations (MK-8669-021 AM1)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Ariad Pharmaceuticals
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer....
Detailed Description
Allocation and Arms Additional Information: All Patients will receive an 8-week open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status...
Eligibility Criteria
Inclusion
- Patient has histologically confirmed stage IIIB/IV non-small cell lung cancer
- Patient has a documented mutation of the KRAS gene
- Patient has evidence of disease progression following 1 but no more than 3 prior chemotherapy regimens
- A minimum of 4 weeks has passed since the most recent anti-cancer treatment
- Women of childbearing potential must have a negative pregnancy test prior to start of therapy and must use an approved contraceptive method for the duration of the study
- Patient has adequate organ function
- Patient has performance status of \<=2 on Eastern Cooperative Oncology Group (ECOG) performance scale
- Patient is \>=18 years of age
Exclusion
- Patient has received more than 2 prior chemotherapy regimens for the treatment lung cancer
- Patient is known to have active brain metastases
- Patient is currently participating or has participated in an investigational drug study within 30 days
- Patient is known to be Human Immunodeficiency Virus (HIV) positive or has a known history of Hepatitis B or C
- Patient has an active infection requiring prescribed intervention
- Patient has newly diagnosed or un-controlled Type 1 or 2 diabetes
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00818675
Start Date
March 1 2009
End Date
August 1 2012
Last Update
January 21 2015
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