Back to resultsA Study of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations (MK-8669-021 AM1)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lead-In Ridaforolimus
Comparator: Blinded Ridaforolimus
Comparator: Blinded Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ridaforolimus
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) in the randomized population
Secondary Outcome Measures
Overall response rate (ORR) in the full analysis population
Overall survival (OS) in the full analysis population
OS in the randomized population
PFS in the full analysis population
Full Information
NCT ID
NCT00818675
First Posted
January 7, 2009
Last Updated
January 19, 2015
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Ariad Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00818675
Brief Title
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)
Official Title
A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Ariad Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ridaforolimus
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lead-In Ridaforolimus
Other Intervention Name(s)
MK-8669; AP23573, Deforolimus (until May, 2009)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Comparator: Blinded Ridaforolimus
Other Intervention Name(s)
MK-8669; AP23573, Deforolimus (until May, 2009)
Intervention Description
Four tablets of blinded ridaforolimus administered daily for 5 consecutive days each week followed by 2 days days of treatment holiday
Intervention Type
Drug
Intervention Name(s)
Comparator: Blinded Placebo
Intervention Description
Four tablets of blinded placebo (to match ridaforolimus) administered daily for 5 consecutive days each week followed by 2 days of treatment holiday
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) in the randomized population
Time Frame
Randomization (Week 8) and every 8 weeks until progressive disease or death
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) in the full analysis population
Time Frame
Study entry (Visit 1) and every 8 weeks until progressive disease or death
Title
Overall survival (OS) in the full analysis population
Time Frame
From study entry (Visit 1) to death due to any cause
Title
OS in the randomized population
Time Frame
From study entry (Visit 1) to death due to any cause
Title
PFS in the full analysis population
Time Frame
Study entry (Visit 1) and every 8 weeks until progressive disease or death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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)
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