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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00924989




Registration number
NCT00924989
Ethics application status
Date submitted
17/06/2009
Date registered
18/06/2009
Date last updated
31/08/2018

Titles & IDs
Public title
A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
Secondary ID [1] 0 0
2009-012820-97
Secondary ID [2] 0 0
OSI-906-301
Universal Trial Number (UTN)
Trial acronym
GALACCTIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adrenocortical Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OSI-906
Other interventions - Placebo

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

Placebo Comparator: Arm B: Placebo - Matching placebo twice daily


Treatment: Drugs: OSI-906
Administered orally

Other interventions: Placebo
Matching placebo administered orally

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival of single agent OSI-906 versus placebo - Time from date of randomization until time of documented death
Timepoint [1] 0 0
33 months
Secondary outcome [1] 0 0
Progression-free survival - Time from randomization to disease progression based on RECIST version 1.1 or death due to any cause, whichever comes first
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Best overall response rate - Proportion of patients with a best overall response of CR or PR based on RECIST criteria
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Duration of response - Time from date of the first documented response (CP/PR) to documented progression or death due to underlying cancer
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Time to deterioration in Quality of Life - Measured by European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Safety assessed via physical exams, vital signs, laboratory assessments, electrocardiograms, and adverse events
Timepoint [6] 0 0
24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital Department of Endocrinology - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Hampshire
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
France
State/province [14] 0 0
Lille
Country [15] 0 0
France
State/province [15] 0 0
Lyon
Country [16] 0 0
France
State/province [16] 0 0
Marseille
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Pessac
Country [19] 0 0
France
State/province [19] 0 0
Villejuif
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Munich
Country [22] 0 0
Germany
State/province [22] 0 0
Wuerzburg
Country [23] 0 0
Italy
State/province [23] 0 0
Orbassano
Country [24] 0 0
Italy
State/province [24] 0 0
Rome
Country [25] 0 0
Netherlands
State/province [25] 0 0
Amsterdam
Country [26] 0 0
Netherlands
State/province [26] 0 0
Eindhoven
Country [27] 0 0
Netherlands
State/province [27] 0 0
Rotterdam
Country [28] 0 0
Poland
State/province [28] 0 0
Gliwice
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Leeds
Country [30] 0 0
United Kingdom
State/province [30] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00924989
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Astellas Pharma Global Development
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications