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A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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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

- 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:


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:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

August 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms