A Phase 2 interventional study of Lead-In Ridaforolimus and Comparator: Blinded Ridaforolimus in Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-21.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
Drug: Lead-In Ridaforolimus · Drug: Comparator: Blinded Ridaforolimus
Drug: Lead-In Ridaforolimus · Drug: Comparator: Blinded Placebo
Four 10mg tablets of ridaforolimus once daily for five consecutive days each week followed by 2 days days of treatment holiday, during the 8 week lead in treatment period.
Also known as: MK-8669; AP23573, Deforolimus (until May, 2009)
Four tablets of blinded ridaforolimus administered daily for 5 consecutive days each week followed by 2 days days of treatment holiday
Also known as: MK-8669; AP23573, Deforolimus (until May, 2009)
Four tablets of blinded placebo (to match ridaforolimus) administered daily for 5 consecutive days each week followed by 2 days of treatment holiday
Progression-free survival (PFS) in the randomized population
Time frame: Randomization (Week 8) and every 8 weeks until progressive disease or death
Overall response rate (ORR) in the full analysis population
Time frame: Study entry (Visit 1) and every 8 weeks until progressive disease or death
Overall survival (OS) in the full analysis population
Time frame: From study entry (Visit 1) to death due to any cause
OS in the randomized population
Time frame: From study entry (Visit 1) to death due to any cause
PFS in the full analysis population
Time frame: Study entry (Visit 1) and every 8 weeks until progressive disease or death
No study locations are listed for this record.
This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC