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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00924989
First received: June 17, 2009
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Adrenocortical Carcinoma
Drug: OSI-906
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Overall survival of single agent OSI-906 versus placebo [ Time Frame: 33 months ] [ Designated as safety issue: No ]
    Time from date of randomization until time of documented death


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Time from randomization to disease progression based on RECIST version 1.1 or death due to any cause, whichever comes first

  • Disease control rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), based on RECIST criteria

  • Best overall response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Proportion of patients with a best overall response of CR or PR based on RECIST criteria

  • Duration of response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Time from date of the first documented response (CP/PR) to documented progression or death due to underlying cancer

  • Time to deterioration in Quality of Life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Measured by European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires

  • Safety assessed via physical exams, vital signs, laboratory assessments, electrocardiograms, and adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 139
Study Start Date: September 2009
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: OSI-906
150 mg twice daily
Drug: OSI-906
Administered orally
Other Name: linsitinib
Placebo Comparator: Arm B: Placebo
Matching placebo twice daily
Other: Placebo
Matching placebo administered orally

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

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924989

  Hide Study Locations
Locations
United States, Arizona
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, California
University of Southern California
Los Angeles, California, United States, 90033
UCLA
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Denver Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-2200
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New Hampshire
Dartmouth Medical School
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
Duke Clinical Cancer Trials Services
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43202
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6307
United States, Texas
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75230
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Australia, New South Wales
Royal North Shore Hospital Department of Endocrinology
St Leonards, New South Wales, Australia, 2065
Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
PMH - Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2W 1T8
France
CHRU Lille, Clinique Endocrinologique Marc Linquette
Lille, France, 59037 cedex
Centre Léon Bérard
Lyon, France, 69008
Institut Paoli-Calmettes
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
Germany
Charite Universitaetsmedizin
Berlin, Germany, 10117
LMU München
Munich, Germany, 80336
Universitaets Klinikum Wuerzburg
Wuerzburg, Germany, 97080
Italy
Universita di Torino
Orbassano, Italy, 10043
Università Cattolica del Sacro Cuore
Rome, Italy, 00168
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Maxima Medisch Centrum (MMC)
Eindhoven, Netherlands, 5631 BM
Erasmus MC Rotterdam
Rotterdam, Netherlands, 3015 CE
Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach
Gliwice, Poland, 44-101
United Kingdom
St. James' University hospital
Leeds, United Kingdom, LS9 7TF
Royal Marsden NHS Trust
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00924989     History of Changes
Other Study ID Numbers: OSI-906-301, 2009-012820-97
Study First Received: June 17, 2009
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Astellas Pharma Inc:
ACC
Adrenocortical carcinoma
OSI-906
Insulin-like growth factor-1 receptor (IGF-1R)
GALACCTIC

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 September 18, 2014