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Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
This study is currently recruiting participants.
Verified by OSI Pharmaceuticals, July 2010
First Received: June 17, 2009   Last Updated: August 19, 2010   History of Changes
Sponsor: OSI Pharmaceuticals
Information provided by: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00924989
  Purpose

A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic ACC who received at least 1 but no more than 2 prior drug regimens


Condition Intervention Phase
Adrenocortical Carcinoma (ACC)
Drug: OSI-906
Other: Placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:
  • Overall survival of single agent OSI-906 vs placebo [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Best overall response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics (PK), Pharmacodynamics (PD) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: August 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Arm A: Single agent OSI-906 administered orally at a dose of 150 mg twice daily
Drug: OSI-906
OSI-906 administered orally at a dose of 150 mg twice daily
2: Placebo Comparator
Arm B: Matching placebo administered orally twice daily
Other: Placebo
Matching placebo administered orally twice daily

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 cytotoxis chemotherapy for ACC, and ECOG performance status, and use of >= 1 oral antihyperglycemic therapy at randomization

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adrenocortical carcinoma that is locally advanced or metastatic and not amenable to surgical resection.
  • Measurable disease according to RECIST (version 1.1).
  • Age >= 18 years.
  • ECOG 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924989

Contacts
Contact: OSIP Medical Information 800.572.1932 medical-information@osip.com

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Sponsors and Collaborators
OSI Pharmaceuticals
Investigators
Study Director: Pilar Nava-Parada, M.D. OSI Pharmaceuticals
  More Information

No publications provided

Responsible Party: OSI Pharmaceuticals ( Dr. Ronit Simantov, Vice President, Clinical Development )
ClinicalTrials.gov Identifier: NCT00924989     History of Changes
Other Study ID Numbers: OSI-906-301
Study First Received: June 17, 2009
Last Updated: August 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:
ACCAdrenocortical carcinomaOSI-906IGF-1R

Additional relevant MeSH terms:
Carcinoma
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 31, 2010