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
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Full eligibility criteria for NCT00924989
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Histologically confirmed adrenocortical carcinoma that is locally advanced or metastatic and not amenable to surgical resection.
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2
Predicted life expectancy >= 12 weeks.
At least 1 but no more than 2 prior drug regimens (including molecular targeted therapy, systemic cytotoxic chemotherapy, biologics, and/or vaccines) for locally advanced/metastatic ACC.
A minimum of 3 weeks must have elapsed between the end of prior treatment and randomization.
All patients must have received prior mitotane, either as neoadjuvant, adjuvant, or locally advanced/metastatic therapy.
Adjuvant and neoadjuvant mitotane therapy will not be counted as prior drug regimens or as systemic cytotoxic chemotherapy.
Prior radiation therapy is permitted provided patients have recovered from the acute, toxic effects of radiotherapy prior to randomization.
A minimum of 21 days must have elapsed between the end of radiotherapy and randomization.
Prior surgery is permitted provided that adequate wound healing has occurred prior to randomization.
Fasting glucose < = 150 mg/dL (8.3 mmol/L).
Adequate hematopoietic, hepatic, and renal function defined as follows: Neutrophil count >= 1.5 x 10^9 /L;
Platelet count >= 100 x 10^9 /L;
Bilirubin <= 1.5 x Upper Limit of Normal (ULN);
AST and ALT <= 2.5 x ULN, or <= 5 x ULN if patient has documented liver metastases or received prior mitotane therapy; and
Serum creatinine <= 1.5 x ULN or <= 2.0 x ULN if the patient has received prior cisplatin.
Patients, both males and females, with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must agree to practice effective contraceptive measures throughout the study.
Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to randomization.
Patients must provide verbal and written informed consent to participate in the study.
Radiologically-confirmed progressive disease within 6 months prior to randomization.
Concurrent use of non-insulinotropic oral antihyperglycemic therapy is permitted if the dose has been stable for >= 4 weeks at the time of randomization.
Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy.
Prior IGF-1R inhibitor therapy.
Malignancy other than ACC within the past 3 years. Exceptions: resected basal cell or squamous cell carcinoma of the skin; cured in situ cervical carcinoma; cured ductal carcinoma in situ of the breast; and/or cured superficial bladder cancer.
History of significant cardiovascular disease unless the disease is well-controlled.
Significant cardiac diseases includes second/third degree heart block; clinically significant ischemic heart disease; mean QTcF interval > 450 msec at screening;
poorly controlled hypertension; congestive heart failure of New York Heart Association
(NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea).
History of cerebrovascular accident (CVA) within 6 months prior to randomization or that resulted in ongoing neurologic instability.
Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing.
Active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to randomization) that would impair the ability of the patient to receive study drug.
History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.
Pregnant or breast-feeding females.
Symptomatic brain metastases that are not stable, require steroids, are potentially life threatening, or that have required radiation within 28 days prior to randomization.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug.
All locations for NCT00924989
United States (14)
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
University of Southern California
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
University of Colorado Denver Cancer Center
Aurora, Colorado, United States, 80045
University of Miami
Miami, Florida, United States, 33136
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Michigan
Ann Arbor, Michigan, United States, 48109-2200
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Dartmouth Medical School
Lebanon, New Hampshire, United States, 03756
Duke Clinical Cancer Trials Services
Durham, North Carolina, United States, 27710
Ohio State University
Columbus, Ohio, United States, 43202
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6307
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75230
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Royal North Shore Hospital Department of Endocrinology
St Leonards, New South Wales, Australia, 2065
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
PMH - Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2W 1T8
CHRU Lille, Clinique Endocrinologique Marc Linquette
Lille, France, 59037 cedex
Centre Léon Bérard
Lyon, France, 69008
Marseille, France, 13273 cedex 09
Hôpital Cochin-Saint Vincent de Paul
Paris, France, 75679 Cedex 14
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, France, 33604 CEDEX
Institut Gustave Roussy
Villejuif, France, 94805 cedex
Berlin, Germany, 10117
Munich, Germany, 80336
Universitaets Klinikum Wuerzburg
Wuerzburg, Germany, 97080
Universita di Torino
Orbassano, Italy, 10043
Università Cattolica del Sacro Cuore
Rome, Italy, 00168
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Maxima Medisch Centrum (MMC)
Eindhoven, Netherlands, 5631 BM
Erasmus MC Rotterdam
Rotterdam, Netherlands, 3015 CE
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach
Gliwice, Poland, 44-101
United Kingdom (2)
St. James' University hospital
Leeds, United Kingdom, LS9 7TF
Royal Marsden NHS Trust
London, United Kingdom, SW3 6JJ
View full eligibility
Tris trial is registered with FDA with number: NCT00924989. The sponsor of the trial is Astellas Pharma Inc and it is looking for 139 volunteers for the current phase.
Official trial title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
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