A Randomized, Double-Blind Placebo-Controlled Phase 3 Study of OSI-906 in Patients with Locally Advanced or Metastatic Adrenocortical Carcinoma - OSI-906-301

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10001388; MedDRA version: 9.1Level: PTClassification code 10001388; Adrenocortical Carcinoma

• Registration Number: EUCTR2009-012820-97-IT
• Lead Sponsor: OSI PHARMACEUTICALS INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-23
• Last Update Posted: 18 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Inclusion Criteria:
1. Histologically confirmed adrenocortical carcinoma that is locally advanced or metastatic and not amenable to surgical resection.
2. Measurable disease according to RECIST (version 1.1).
3. Radiologically-confirmed progressive disease within 6 months prior to randomization.
4. Age 18 years.
5. ECOG PS 2.
6. Predicted life expectancy 12 weeks.
7. 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.
a. All patients must have received prior mitotane, either as neoadjuvant, adjuvant, or locally advanced/metastatic therapy.
b. Adjuvant and neoadjuvant mitotane therapy will not be counted as prior drug regimens or as systemic cytotoxic chemotherapy.
8. 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.
9. Prior surgery is permitted provided that adequate wound healing has occurred prior to randomization.
10. Fasting glucose 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic oral antihyperglycemic therapy is permitted if the dose has been stable for 4 weeks at the time of randomization.
11. Adequate hematopoietic, hepatic, and renal function defined as follows: Neutrophil count 1.5 x 109/L; Platelet count 100 x 109/L; 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.
12. 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.
13. Patients must provide verbal and written informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy.
2. Prior IGF-1R inhibitor therapy.
3. History of prior malignancy, except for resected basal cell or squamous cell carcinoma of the skin, cured in situ cervical carcinoma, cured ductal carcinoma in situ of the breast, or other cancers where the patient has been disease-free for 3 years.
4. 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; 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).
5. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that resulted in ongoing neurologic instability.
6. Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing.
7. 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.
8. 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.
9. Pregnant or breast-feeding females.
10. Symptomatic brain metastases that are not stable, require steroids, are potentially life-threatening, or that have required radiation within 28 days prior to randomization.
11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified