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SarcomaNCT00210665

A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment

A study testing Trabectedin in people with Sarcoma, run by Janssen Research & Development, LLC at 36 sites in 3 countries.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Sarcoma
What is being tested?
Trabectedin
Type of treatment
Injection or infusion
How many people
Not given
Where
36 sitesin 3 countries
Study dates
Start not givento not given
Phase
Expanded access
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Unresectable advanced or metastatic histologically proven soft tissue sarcoma (STS). Eligibility will include adult participants with desmoplastic small round cell tumor
  • Must have relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment or intolerant to prior standard of care treatment with chemotherapy due to safety issues
  • Recovery from toxic effects of prior therapies to Grade 1 or better according to National Cancer Institute-Common Terminology Criteria of Adverse Events (criteria used to grade the severity of toxic effects on a scale from 0 to 5 - Grade 1 = mild in severity, Grade 0 = no severity)
  • Clinical test results within acceptable limits (ie, hematologic, clinical chemistry and hepatic function test results)
  • Female participants must be postmenopausal, surgically sterile, abstinent, or if sexually active, be practicing 2 effective methods of birth control (eg, prescription hormonal contraceptive, intrauterine device, double-barrier method [eg, condoms, occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, cream, gel, film, or suppository]), before entry, and must agree to continue to use these same methods of contraception throughout the study and for 3 months thereafter. Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm for a minimum of 5 months after treatment discontinuation

Who cannot join

  • Diagnosis of Ewing's sarcoma or osteosarcoma, less than 3 weeks from last dose of radiation, systemic cytotoxic therapy (or 4 half lives, whichever is longer)
  • Active symptomatic viral hepatitis or chronic liver disease
  • Significant uncontrolled cardiac condition, including New York Heart Association Class II or greater heart failure, uncontrolled angina pectoris, myocardial infarction within 6 months before enrollment, significant pericardial disease, or uncontrolled or arrhythmias
  • Active infection
  • Female participant who is pregnant or breastfeeding

Trial locations and contacts

36 sites in 3 countries.

36 sites in 3 countries

United States31 sites

  • Study site

    Anchorage, Alaska

  • Study site

    Ann Arbor, Michigan

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Boston, Massachusetts

  • Study site

    Charleston, South Carolina

  • Study site

    Cleveland, Ohio

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Daytona Beach, Florida

  • Study site

    Detroit, Michigan

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Louisville, Kentucky

  • Study site

    Metairie, Louisiana

  • Study site

    Milwaukee, Wisconsin

  • Study site

    New York, New York

  • Study site

    Newark, New Jersey

  • Study site

    Omaha, Nebraska

  • Study site

    Overland Park, Kansas

  • Study site

    Park Ridge, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Rochester, Minnesota

  • Study site

    Saint Joseph, Missouri

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Monica, California

  • Study site

    Seattle, Washington

  • Study site

    Tulsa, Oklahoma

Other trials in United States

Canada4 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Edmonton

  • Study site

    Toronto, Ontario

Other trials in Canada

Israel1 site

  • Study site

    Tel Aviv

Other trials in Israel

About this study

Official title: A Multicenter, Open-Label, Single-Arm Study of YONDELIS (Trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment

The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment.

Read the detailed description

This is a multicenter, open-label (all people know the identity of the intervention), single-arm study. It will consist of 2 Phases: a Screening Phase (up to 21 days before the first dose administration), and Treatment Phase (for patients meeting the continuation criteria). During the Treatment Phase, patients will receive a dose of 1.5 mg/m2 trabectedin intravenous formulation administered as a 24-hour infusion on Day 1 of each suggested 21-day treatment cycle. All patients will receive 20 mg dexamethasone (or corticosteroid equivalent to dexamethasone). Number of cycles is not specified for this study. Patients may continue to receive treatment as long as they obtain an overall clinical benefit, ie, until there is clear evidence of disease progression or unacceptable toxicity, as judged by the investigator. Trabectedin is the first of a new class of antitumor agents. Previous studies with trabectedin in patients who had been previously treated for soft tissue sarcoma have suggested that treatment with trabectedin resulted in tumor shrinkage, disease stabilization, and improved survival rates. However, hematologic toxicity, hepatic toxicity, and renal impairment were also observed in these patients. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment in patients previously treated for soft tissue sarcoma who are not expected to benefit from currently available therapeutic options for treatment of soft tissue sarcoma. Safety will be monitored throughout the study.

Conditions
Sarcoma
Being tested
Trabectedin
Keywords
Sarcoma, Soft tissue sarcoma, Standard care, Trabectedin, Antitumor agent, Safety
Medical subject headings
Sarcoma

What participants receive

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

  • TrabectedinDrug

    Type= exact number, unit= mg/m2, number= 1.5, form= intravenous infusion, route= intravenous use. 1.5mg/m2 as 24hr infusion on day 1 of each 21 day cycle

Timeline

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

  1. First posted21 Sep 2005 (estimated)

Resources

More details

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

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT00210665
Sponsor's protocol ID
CR003583
Other IDs
ET743SAR3002
Status last verified
Oct 2017
First submitted
13 Sep 2005
Last updated
10 Oct 2017
Results posted
No

Publications

  • Samuels BL, Chawla S, Patel S, von Mehren M, Hamm J, Kaiser PE, Schuetze S, Li J, Aymes A, Demetri GD. Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study. Ann Oncol. 2013 Jun;24(6):1703-9. doi: 10.1093/annonc/mds659. Epub 2013 Feb 5.

    PubMed 23385197

  • Charytonowicz E, Terry M, Coakley K, Telis L, Remotti F, Cordon-Cardo C, Taub RN, Matushansky I. PPARgamma agonists enhance ET-743-induced adipogenic differentiation in a transgenic mouse model of myxoid round cell liposarcoma. J Clin Invest. 2012 Mar;122(3):886-98. doi: 10.1172/JCI60015. Epub 2012 Feb 1.

    PubMed 22293175

Questions about this trial

What is this clinical trial studying?

A study testing Trabectedin in people with Sarcoma, run by Janssen Research & Development, LLC at 36 sites in 3 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Canada, Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00210665, which also lists 2 linked publications.

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 10 Oct 2017.

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