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RecruitingLast updated: 15 August 2023

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

Clinical summary

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.

Conditions

This trial is treating patients with leiomyosarcoma.

Cancer

Sarcoma Cancers Sarcoma

Age

People18+

Phase

II/III

Trial Acronym

SUNRISE

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Trial Identifiers

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Commercial Sponsor

PTC Therapeutics

Scientific Title

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

Eligibility

Inclusion

  • 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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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