Clinical Trial: A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
Brief Summary: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens
Detailed Summary: Patients will be randomized 2:1 to receive either single agent OSI-906 (Arm A) or placebo (Arm B) and will be stratified according to prior systemic cytotoxic chemotherapy for ACC, and Eastern Cooperative Oncology Group (ECOG) performance status, and use of >= 1 oral antihyperglycemic therapy at randomization
Sponsor: Astellas Pharma Inc
Current Primary Outcome: Overall survival of single agent OSI-906 versus placebo [ Time Frame: 33 months ]
Original Primary Outcome: Overall survival of single agent OSI-906 vs placebo [ Time Frame: 24 months ]
Current Secondary Outcome:
- Progression-free survival [ Time Frame: 24 months ]Time from randomization to disease progression based on RECIST version 1.1 or death due to any cause, whichever comes first
- Disease control rate [ Time Frame: 24 months ]Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), based on RECIST criteria
- Best overall response rate [ Time Frame: 24 months ]Proportion of patients with a best overall response of CR or PR based on RECIST criteria
- Duration of response [ Time Frame: 24 months ]Time from date of the first documented response (CP/PR) to documented progression or death due to underlying cancer
- Time to deterioration in Quality of Life [ Time Frame: 24 months ]Measured by European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires
- Safety assessed via physical exams, vital signs, laboratory assessments, electrocardiograms, and adverse events [ Time Frame: 24 months ]
Original Secondary Outcome:
- Progression-free survival [ Time Frame: 24 months ]
- Disease control rate [ Time Frame: 24 months ]
- Best overall response rate [ Time Frame: 24 months ]
- Duration of response [ Time Frame: 24 months ]
- Quality of Life [ Time Frame: 24 months ]
- Safety profile [ Time Frame: 24 months ]
- Pharmacokinetics (PK), Pharmacodynamics (PD) [ Time Frame: 24 months ]
Information By: Astellas Pharma Inc
Dates:
Date Received: June 17, 2009
Date Started: September 2009
Date Completion:
Last Updated: July 10, 2013
Last Verified: July 2013