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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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Lead-In Ridaforolimus Drug: Comparator: Blinded Ridaforolimus Drug: Comparator: Blinded Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations |
- Progression-free survival (PFS) in the randomized population [ Time Frame: Randomization (Week 8) and every 8 weeks until progressive disease or death ] [ Designated as safety issue: No ]
- Overall response rate (ORR) in the full analysis population [ Time Frame: Study entry (Visit 1) and every 8 weeks until progressive disease or death ] [ Designated as safety issue: No ]
- Overall survival (OS) in the full analysis population [ Time Frame: From study entry (Visit 1) to death due to any cause ] [ Designated as safety issue: No ]
- OS in the randomized population [ Time Frame: From study entry (Visit 1) to death due to any cause ] [ Designated as safety issue: No ]
- PFS in the full analysis population [ Time Frame: Study entry (Visit 1) and every 8 weeks until progressive disease or death ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | March 2009 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ridaforolimus |
Drug: Lead-In Ridaforolimus
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.
Other Names:
Drug: Comparator: Blinded Ridaforolimus
Four tablets of blinded ridaforolimus administered daily for 5 consecutive days each week followed by 2 days days of treatment holiday
Other Names:
|
| Placebo Comparator: Placebo |
Drug: Lead-In Ridaforolimus
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.
Other Names:
Drug: Comparator: Blinded Placebo
Four tablets of blinded placebo (to match ridaforolimus) administered daily for 5 consecutive days each week followed by 2 days of treatment holiday
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00818675 History of Changes |
| Other Study ID Numbers: | 8669-021, 2008_599 |
| Study First Received: | January 7, 2009 |
| Last Updated: | October 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Sirolimus |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013