Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

SUNRISE : A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

Two/ThreePhase Two/Three

18+Age Over 18

Sarcoma<br/>CancersCancer LocationSarcoma
Cancers

Systemic therapy | SarcomaLeiomyosarcoma

Trial Overview Read MoreRead more

This phase II/III study is assessing how safe and effective a new oral drug (unesbulin), compared to a placebo, is when given in combination with chemotherapy (dacarbazine) in people with inoperable, metastatic, relapsed or refractory leiomyosarcoma.
 

This trial is treating patients with leiomyosarcoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma

Commercial Sponsor

PTC Therapeutics

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or Placebo Comparator Arm. In the Experimental Arm, participants will receive unesbulin (300mg) tablets administered orally, twice weekly, in each 3-week treatment cycle, in combination with dacarbazine (1000mg/m^2) given intravenously once every 21 days. In the Placebo Comparator Arm, participants will receive placebo tablets administered orally twice weekly in each 3-week treatment cycle, in combination with dacarbazine (1000mg/m^2) administered intravenously once every 21 days.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Sally Mongta
PCCTU.Gynae@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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