A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
GALACCTIC
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
2 other identifiers
interventional
139
9 countries
35
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2009
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2009
CompletedFirst Posted
Study publicly available on registry
June 19, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2012
CompletedNovember 20, 2024
November 1, 2024
2.6 years
June 17, 2009
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival of single agent OSI-906 versus placebo
Time from date of randomization until time of documented death
33 months
Secondary Outcomes (6)
Progression-free survival
24 months
Disease control rate
24 months
Best overall response rate
24 months
Duration of response
24 months
Time to deterioration in Quality of Life
24 months
- +1 more secondary outcomes
Study Arms (2)
Arm A: OSI-906
EXPERIMENTAL150 mg twice daily
Arm B: Placebo
PLACEBO COMPARATORMatching placebo twice daily
Interventions
Eligibility Criteria
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);
- +7 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
University of Southern California
Los Angeles, California, 90033, United States
UCLA
Los Angeles, California, 90095, United States
University of Colorado Denver Cancer Center
Aurora, Colorado, 80045, United States
University of Miami
Miami, Florida, 33136, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109-2200, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Dartmouth Medical School
Lebanon, New Hampshire, 03756, United States
Duke Clinical Cancer Trials Services
Durham, North Carolina, 27710, United States
Ohio State University
Columbus, Ohio, 43202, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307, United States
Mary Crowley Cancer Research Center
Dallas, Texas, 75230, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Royal North Shore Hospital Department of Endocrinology
St Leonards, New South Wales, 2065, Australia
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6, Canada
PMH - Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2W 1T8, Canada
CHRU Lille, Clinique Endocrinologique Marc Linquette
Lille, 59037 cedex, France
Centre Léon Bérard
Lyon, 69008, France
Institut Paoli-Calmettes
Marseille, 13273 cedex 09, France
Hôpital Cochin-Saint Vincent de Paul
Paris, 75679 Cedex 14, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604 CEDEX, France
Institut Gustave Roussy
Villejuif, 94805 cedex, France
Charite Universitaetsmedizin
Berlin, 10117, Germany
LMU München
Munich, 80336, Germany
Universitaets Klinikum Wuerzburg
Würzburg, 97080, Germany
Universita di Torino
Orbassano, 10043, Italy
Università Cattolica del Sacro Cuore
Rome, 00168, Italy
Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
Maxima Medisch Centrum (MMC)
Eindhoven, 5631 BM, Netherlands
Erasmus MC Rotterdam
Rotterdam, 3015 CE, Netherlands
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach
Gliwice, 44-101, Poland
St. James' University hospital
Leeds, LS9 7TF, United Kingdom
Royal Marsden NHS Trust
London, SW3 6JJ, United Kingdom
Related Publications (1)
Fassnacht M, Berruti A, Baudin E, Demeure MJ, Gilbert J, Haak H, Kroiss M, Quinn DI, Hesseltine E, Ronchi CL, Terzolo M, Choueiri TK, Poondru S, Fleege T, Rorig R, Chen J, Stephens AW, Worden F, Hammer GD. Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. 2015 Apr;16(4):426-35. doi: 10.1016/S1470-2045(15)70081-1. Epub 2015 Mar 18.
PMID: 25795408DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2009
First Posted
June 19, 2009
Study Start
December 1, 2009
Primary Completion
July 11, 2012
Study Completion
October 8, 2012
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.