A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations
18 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression-free survival (PFS) in the randomized population
Outcome Time Frame:
Randomization (Week 8) and every 8 weeks until progressive disease or death
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
8669-021
NCT ID:
NCT00818675
Start Date:
March 2009
Completion Date:
August 2012
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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