A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Adrenocortical Carcinoma

In brief

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

Key facts

Study ID

NCT00924989

Run by

Astellas Pharma Inc

People needed

139

Starts

2009-12-01

Expected to finish

2012-10-08

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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) (version 1.1).
• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Ohio State University — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Mary Crowley Cancer Research Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Royal North Shore Hospital Department of Endocrinology — St Leonards, New South Wales, Australia
• St. Joseph's Hospital — Hamilton, Ontario, Canada
• PMH - Princess Margaret Hospital — Toronto, Ontario, Canada
• Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada
• CHRU Lille, Clinique Endocrinologique Marc Linquette — Lille, France
• Centre Léon Bérard — Lyon, France
• Institut Paoli-Calmettes — Marseille, France
• Hôpital Cochin-Saint Vincent de Paul — Paris, France
• CHU Bordeaux - Hôpital Haut-Lévêque — Pessac, France
• Institut Gustave Roussy — Villejuif, France
• Charite Universitaetsmedizin — Berlin, Germany

Full record on ClinicalTrials.gov

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