Trabectedin for Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

  • STATUS
    Recruiting
  • participants needed
    1200
  • sponsor
    University of Medicine and Dentistry New Jersey
Updated on 7 November 2020
trabectedin
soft tissue sarcoma
metastatic soft tissue sarcoma

Summary

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

Description

This study is designed to accommodate individual requests for treatment with trabectedin before the drug becomes commercially available. In regions where trabectedin becomes commercially available and reimbursable in that particular country, an administrative cutoff for further accrual will be set. Subjects with STS who have relapsed following standard of care treatment or who are refractory to or intolerant of standard therapies but who may benefit from treatment may participate in this study. The safety profile of the drug will be further evaluated. Eligible subjects will receive a dose of 1.5 mg/m2 trabectedin intravenous (i.v.) formulation administered as a 24-hour infusion on Day 1 of each 17- to 49-day treatment cycle. Tumor assessment will be performed prior to administration of the first dose (Cycle 1, Day 1) and thereafter approximately every 2 cycles according to institutional standards. The number of cycles is not specified for this study. Subjects may continue to receive treatment as long as they derive an overall clinical benefit, i.e., until there is clear evidence of disease progression or unacceptable toxicity, as judged by the investigator. Safety evaluation will include physical examinations, monitoring vital signs and adverse events, and collecting hematology and clinical chemistry test results. Minimal efficacy data will be collected and includes tumor assessments and survival information. An administrative cutoff for further study accrual will be set in regions where trabectedin commercially becomes available and reimbursable in that particular country if applicable.

Details
Condition Sarcoma
Treatment trabectedin
Clinical Study IdentifierNCT00707109
SponsorUniversity of Medicine and Dentistry New Jersey
Last Modified on7 November 2020

Eligibility

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note