Clinical Trials Logo
  1. Home
  2. Advanced Soft Tissue Sarcoma
  3. NCT04204941

Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma

Advanced Soft-tissue Sarcoma Clinical Trial

Official title:
A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma

Clinical Trial Summary

The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue. Part 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study. Part 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse. The study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma

Clinical Trial Description

The open-label phase 1b portion is designed to evaluate the safety of the combination of tazemetostat + doxorubicin, as well as to establish the maximum tolerated dose (MTD) and the RP3D. The phase 3 portion of the clinical trial aims to compare tazemetostat + doxorubicin to the current front-line standard treatment, single-agent doxorubicin + placebo, when used as first-line treatment in locally advanced unresectable or metastatic ES. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04204941
Study type Interventional
Source Ipsen
Contact Ipsen Recruitment Enquiries
Phone See e mail
Email clinical.trials@ipsen.com
Status Recruiting
Phase Phase 3
Start date December 19, 2019
Completion date January 1, 2030
View Details
See also
  Status Clinical Trial Phase
Terminated NCT05043649 - Camsirubicin + Pegfilgrastim to Determine MTD in ASTS Phase 1
Recruiting NCT05146440 - Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination With Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor Phase 1/Phase 2
Recruiting NCT05620693 - Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma N/A
Recruiting NCT05809830 - Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas Phase 1/Phase 2
Not yet recruiting NCT06367075 - A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma Phase 2
Recruiting NCT04874311 - Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma Phase 2
Recruiting NCT05876715 - LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma Phase 1/Phase 2
Recruiting NCT04757337 - Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients Phase 3
Recruiting NCT04705818 - Combining Epigenetic And Immune Therapy to Beat Cancer. Phase 2
Terminated NCT05154630 - Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors Phase 1/Phase 2
Recruiting NCT05099666 - Lurbinectedin + Doxorubicin In Leiomyosarcoma Phase 1/Phase 2
Completed NCT03022448 - Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
Recruiting NCT05182164 - Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas Phase 2
Recruiting NCT05180695 - HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas Phase 1/Phase 2
Terminated NCT04780464 - A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma Phase 3