Milademetan versus trabectedin in dedifferentiated liposarcoma (MANTRA)

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Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma (MANTRA)

Agents: Milademetan vs. Trabectedin
Phase III
Status  Recruiting
Sponsor Rain Therapeutics Inc.

Further information: https://www.clinicaltrials.gov/ct2/show/NCT04979442?term=mantra&cond=sarcoma&draw=2&rank=1

 

This is a Phase 3 registration study evaluating the safety and efficacy of milademetan compared to trabectedin in patients with unresectable or metastatic, progressing dedifferentiated liposarcoma.

WHO is the trial for?
  • Patients with advanced unresectable dedifferentiated (DD) liposarcoma
  • Patients must have measurable disease
  • Patients who received 1 or more prior systemic treatments, including at least 1 anthracycline-based regimen, and had progressive disease within 6 months before the Screening Visit
  • Overall health of the patient must be good (ECOG performance status of 0 or 1)

WHAT is the key question that this trial is attempting to answer?

This study aims to investigate a drug called milademetan. The trial tries to find out whether milademetan or trabectedin is more effective in patients with unresectable or metastatic dedifferentiated liposarcoma after at least one prior therapy. In addition, safety and tolerability of the drug(s) is assessed.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

 Phase III of this study is open for recruitment.

WHERE is the trial available?

The trial is being conducted in several study centers in the US, Austria, Belgium, Canada, France, Georgia, Germany, Hong Kong, Italy, Poland, Spain and the UK. For further information please check here: https://www.clinicaltrials.gov/ct2/show/NCT04979442?term=mantra&cond=sarcoma&draw=2&rank=1

Study contact: Clinical Operations (US)-5109535559; Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!

STUDY DESIGN: What does the study look like?

This study has two study arms: all participating patients will be randomly divided (by a computer) in two groups.

The first group will receive milademetan, the other group receives trabectedin. Both drugs will be given until the disease progresses or too limiting side effects occur.

SPAEN Study Registry Milademetan Mantra DDLS

 

 

 

 

 

 

 

 

 

HOW do I get more information?

 Patient organisations supporting sarcoma and/or GIST patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!

CONNECT with other patients on this trial

 If you want to connect with other patients considering or participating in this trial, you can find them here.

SHARE your experience

 You want to share your experience on this trial?
Send us an e-mail to: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

 Not yet available.


Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

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