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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
139
Overall survival of single agent OSI-906 versus placebo
Time from date of randomization until time of documented death
Time frame: 33 months
Progression-free survival
Time from randomization to disease progression based on RECIST version 1.1 or death due to any cause, whichever comes first
Time frame: 24 months
Disease control rate
Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), based on RECIST criteria
Time frame: 24 months
Best overall response rate
Proportion of patients with a best overall response of CR or PR based on RECIST criteria
Time frame: 24 months
Duration of response
Time from date of the first documented response (CP/PR) to documented progression or death due to underlying cancer
Time frame: 24 months
Time to deterioration in Quality of Life
Measured by European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires
Time frame: 24 months
Safety assessed via physical exams, vital signs, laboratory assessments, electrocardiograms, and adverse events
Time frame: 24 months
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TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States
University of Southern California
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
University of Colorado Denver Cancer Center
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Dartmouth Medical School
Lebanon, New Hampshire, United States
Duke Clinical Cancer Trials Services
Durham, North Carolina, United States
...and 25 more locations