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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
With
Ariad Pharmaceuticals
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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)
