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)

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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. Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status. Patients assessed by the investigator to have stable disease after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo. Patients assessed to have partial or complete response will continue on open-label ridaforolimus. Patients assessed to have disease progression will be discontinued from study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Ariad Pharmaceuticals
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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