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)

NCT00818675 | Terminated Phase 2

• 2 other identifiers: 8669-0212008_599
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) in the randomized population

  Randomization (Week 8) and every 8 weeks until progressive disease or death

Secondary Outcomes (4)

• Overall response rate (ORR) in the full analysis population

  Study entry (Visit 1) and every 8 weeks until progressive disease or death

• Overall survival (OS) in the full analysis population

  From study entry (Visit 1) to death due to any cause

• OS in the randomized population

  From study entry (Visit 1) to death due to any cause

• PFS in the full analysis population

  Study entry (Visit 1) and every 8 weeks until progressive disease or death

Study Arms (2)

Ridaforolimus

EXPERIMENTAL

Drug: Lead-In Ridaforolimus; Drug: Comparator: Blinded Ridaforolimus

Placebo

PLACEBO COMPARATOR

Drug: Lead-In Ridaforolimus; Drug: Comparator: Blinded Placebo

Interventions

Lead-In Ridaforolimus DRUG

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)

Placebo; Ridaforolimus

Comparator: Blinded Ridaforolimus DRUG

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)

Ridaforolimus

Comparator: Blinded Placebo DRUG

Four tablets of blinded placebo (to match ridaforolimus) administered daily for 5 consecutive days each week followed by 2 days of treatment holiday

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Ariad Pharmaceuticals: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ridaforolimus

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 21, 2015

Record last verified: 2015-01