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Adrenocortical CarcinomaPhase 3GALACCTICNCT00924989

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

A Phase 3 study testing OSI-906 in people with Adrenocortical Carcinoma, run by Astellas Pharma Inc at 35 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adrenocortical Carcinoma
What is being tested?
OSI-906
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
139 participants
Where
35 sitesin 9 countries
Study dates
1 Dec 2009to 8 Oct 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

35 sites in 9 countries.

35 sites in 9 countries

United States14 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-2200

  • University of Colorado Denver Cancer Center

    Aurora, Colorado, 80045

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Ohio State University

    Columbus, Ohio, 43202

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke Clinical Cancer Trials Services

    Durham, North Carolina, 27710

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Dartmouth Medical School

    Lebanon, New Hampshire, 03756

  • University of Southern California

    Los Angeles, California, 90033

  • UCLA

    Los Angeles, California, 90095

  • University of Miami

    Miami, Florida, 33136

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-6307

  • TGen Clinical Research Service at Scottsdale Healthcare

    Scottsdale, Arizona, 85258

Other trials in United States

France6 sites

  • CHRU Lille, Clinique Endocrinologique Marc Linquette

    Lille, 59037 cedex

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli-Calmettes

    Marseille, 13273 cedex 09

  • Hôpital Cochin-Saint Vincent de Paul

    Paris, 75679 Cedex 14

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604 CEDEX

  • Institut Gustave Roussy

    Villejuif, 94805 cedex

Other trials in France

Canada3 sites

  • St. Joseph's Hospital

    Hamilton, Ontario, L8N 4A6

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2W 1T8

  • PMH - Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany3 sites

  • Charite Universitaetsmedizin

    Berlin, 10117

  • LMU München

    Munich, 80336

  • Universitaets Klinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Netherlands3 sites

  • Academic Medical Center

    Amsterdam, 1105 AZ

  • Maxima Medisch Centrum (MMC)

    Eindhoven, 5631 BM

  • Erasmus MC Rotterdam

    Rotterdam, 3015 CE

Other trials in Netherlands

Italy2 sites

  • Universita di Torino

    Orbassano, 10043

  • Università Cattolica del Sacro Cuore

    Rome, 00168

Other trials in Italy

United Kingdom2 sites

  • St. James' University hospital

    Leeds, LS9 7TF

  • Royal Marsden NHS Trust

    London, SW3 6JJ

Other trials in United Kingdom

Australia1 site

  • Royal North Shore Hospital Department of Endocrinology

    St Leonards, New South Wales, 2065

Other trials in Australia

Poland1 site

  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach

    Gliwice, 44-101

Other trials in Poland

About this study

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

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

Read the 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

Being tested
OSI-906, Placebo
Keywords
Adrenocortical carcinoma, OSI-906, ACC, GALACCTIC, Insulin-like growth factor-1 receptor (IGF-1R)
Medical subject headings
Adrenocortical Carcinoma, Insulin-Like Growth Factor I, Resistance To

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OSI-906Drug

    Also called linsitinib

    Administered orally

  • PlaceboOther

    Matching placebo administered orally

Study groups in NCT00924989
Study groupRoleWhat they receive
Arm A: OSI-906Experimental150 mg twice daily
Receives: Drug: OSI-906
Arm B: PlaceboPlacebo comparatorMatching placebo twice daily
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival of single agent OSI-906 versus placebo

    Time from date of randomization until time of documented death

    Measured: 33 months

Secondary outcomes (6)

  1. Progression-free survival

    Time from randomization to disease progression based on RECIST version 1.1 or death due to any cause, whichever comes first

    Measured: 24 months

  2. 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

    Measured: 24 months

  3. Best overall response rate

    Proportion of patients with a best overall response of CR or PR based on RECIST criteria

    Measured: 24 months

  4. Duration of response

    Time from date of the first documented response (CP/PR) to documented progression or death due to underlying cancer

    Measured: 24 months

  5. Time to deterioration in Quality of Life

    Measured by European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires

    Measured: 24 months

  6. Safety assessed via physical exams, vital signs, laboratory assessments, electrocardiograms, and adverse events

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2009 (estimated)
  2. Study start1 Dec 2009
  3. Primary completion11 Jul 2012
  4. Study completion8 Oct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00924989
Sponsor's protocol ID
OSI-906-301
Other IDs
2009-012820-97, 2009
Acronym
GALACCTIC
Status last verified
Nov 2024
First submitted
17 Jun 2009
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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/.

Publications

  • 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.

    PubMed 25795408

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OSI-906 in people with Adrenocortical Carcinoma, run by Astellas Pharma Inc at 35 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, France, Canada, Germany, Netherlands and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival of single agent OSI-906 versus placebo (time frame: 33 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00924989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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