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

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Brief Title

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

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 Description

      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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall survival of single agent OSI-906 versus placebo

Secondary Outcome

 Progression-free survival

Condition

Adrenocortical Carcinoma

Intervention

OSI-906

Study Arms / Comparison Groups

 Arm A: OSI-906
Description:  150 mg twice daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

139

Start Date

December 1, 2009

Completion Date

October 8, 2012

Primary Completion Date

July 11, 2012

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Medical Director, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00924989

Organization ID

OSI-906-301

Secondary IDs

2009-012820-97

Responsible Party

Sponsor

Study Sponsor

Astellas Pharma Inc


Study Sponsor

Medical Director, Study Director, Astellas Pharma Global Development


Verification Date

August 2018