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

Adrenocortical Carcinoma Clinical Trial

— GALACCTIC  

Official title:

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924989
• Other study ID #: OSI-906-301
• Secondary ID: 2009-012820-97
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2009
• Est. completion date: October 8, 2012

Study information

• Verified date: August 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 8, 2012
• Est. primary completion date: July 11, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adrenocortical Carcinoma
• Carcinoma

Intervention

Drug:
• OSI-906
Administered orally

Other:
• Placebo
Matching placebo administered orally

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital Department of Endocrinology	St Leonards	New South Wales
Canada	St. Joseph's Hospital	Hamilton	Ontario
Canada	Centre hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec
Canada	PMH - Princess Margaret Hospital	Toronto	Ontario
France	CHRU Lille, Clinique Endocrinologique Marc Linquette	Lille
France	Centre Léon Bérard	Lyon
France	Institut Paoli-Calmettes	Marseille
France	Hôpital Cochin-Saint Vincent de Paul	Paris
France	CHU Bordeaux - Hôpital Haut-Lévêque	Pessac
France	Institut Gustave Roussy	Villejuif
Germany	Charite Universitaetsmedizin	Berlin
Germany	LMU München	Munich
Germany	Universitaets Klinikum Wuerzburg	Wuerzburg
Italy	Universita di Torino	Orbassano
Italy	Università Cattolica del Sacro Cuore	Rome
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Maxima Medisch Centrum (MMC)	Eindhoven
Netherlands	Erasmus MC Rotterdam	Rotterdam
Poland	Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach	Gliwice
United Kingdom	St. James' University hospital	Leeds
United Kingdom	Royal Marsden NHS Trust	London
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado Denver Cancer Center	Aurora	Colorado
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Mary Crowley Cancer Research Center	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Clinical Cancer Trials Services	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Dartmouth Medical School	Lebanon	New Hampshire
United States	UCLA	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	TGen Clinical Research Service at Scottsdale Healthcare	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival of single agent OSI-906 versus placebo	Time from date of randomization until time of documented death	33 months
Secondary	Progression-free survival	Time from randomization to disease progression based on RECIST version 1.1 or death due to any cause, whichever comes first	24 months
Secondary	Disease control rate	Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), based on RECIST criteria	24 months
Secondary	Best overall response rate	Proportion of patients with a best overall response of CR or PR based on RECIST criteria	24 months
Secondary	Duration of response	Time from date of the first documented response (CP/PR) to documented progression or death due to underlying cancer	24 months
Secondary	Time to deterioration in Quality of Life	Measured by European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires	24 months
Secondary	Safety assessed via physical exams, vital signs, laboratory assessments, electrocardiograms, and adverse events		24 months

External Links

•   Link to results on the Astellas Clinical Study Results website.