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)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Comparator: Blinded Ridaforolimus

Drug: Lead-In Ridaforolimus

Drug: Comparator: Blinded Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00818675

8669-021

2008_599

Details and patient eligibility

About

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.

Full 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. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)

Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-study.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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