NCT01979393

IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

Completed Phase 2 Last updated 1 August 2025

What this trial tests

Phase 2 trial testing Cabozantinib in Uterine Sarcoma in 58 participants. Completed in 15 January 2024.

Timeline

2 February 2015

Primary endpoint
18 May 2022

15 January 2024

Quick facts

Lead sponsor	European Organisation for Research and Treatment of Cancer - EORTC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	58
Start date	2 February 2015
Primary completion	18 May 2022
Estimated completion	15 January 2024
Sites	15 locations across France, Italy, Netherlands, United Kingdom, Spain

Drugs / interventions tested

• Cabozantinib (CABOZANTINIB) — full drug profile →
• Placebo

Conditions studied

• Uterine Sarcoma — all drugs for Uterine Sarcoma →

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC — full company profile →

Who can join

18 and older, female only, with Uterine Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs that have effects on tumour growth, blood supply, invasion and spread.

Therefore, we want to find out whether taking cabozantinib after treatment with surgery and chemotherapy is effective and safe for patients who responded or had stable disease after their chemotherapy.

All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization or response to the standard chemotherapy will be split into 2 groups (cabozantinib or placebo).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical trial designs for rare diseases: studies developed and discussed by the International Rare Cancers Initiative.
   Bogaerts J, Sydes MR, Keat N, McConnell A, et al · · 2015 · cited 92× · PMID 25542058 · DOI 10.1016/j.ejca.2014.10.027
2. Uterine sarcoma - current perspectives.
   Benson C, Miah AB. · · 2017 · cited 64× · PMID 28919822 · DOI 10.2147/ijwh.s117754
3. BDNF and its signaling in cancer.
   Malekan M, Nezamabadi SS, Samami E, Mohebalizadeh M, et al · · 2023 · cited 48× · PMID 36173463 · DOI 10.1007/s00432-022-04365-8
4. A phase II trial to assess the activity of gemcitabine and docetaxel as first line chemotherapy treatment in patients with unresectable leiomyosarcoma.
   Seddon B, Scurr M, Jones RL, Wood Z, et al · · 2015 · cited 42× · PMID 25987978 · DOI 10.1186/s13569-015-0029-8
5. Potential Therapeutic Targets in Uterine Sarcomas.
   Cuppens T, Tuyaerts S, Amant F. · · 2015 · cited 32× · PMID 26576131 · DOI 10.1155/2015/243298
6. The treatment landscape in thyroid cancer: a focus on cabozantinib.
   Weitzman SP, Cabanillas ME. · · 2015 · cited 24× · PMID 26316818 · DOI 10.2147/cmar.s68373
7. Management Strategies in Advanced Uterine Leiomyosarcoma: Focus on Trabectedin.
   Amant F, Lorusso D, Mustea A, Duffaud F, et al · · 2015 · cited 23× · PMID 26089739 · DOI 10.1155/2015/704124
8. Clinical Activity of Single-Agent Cabozantinib (XL184), a Multi-receptor Tyrosine Kinase Inhibitor, in Patients with Refractory Soft-Tissue Sarcomas.
   O'Sullivan Coyne G, Kummar S, Hu J, Ganjoo K, et al · · 2022 · cited 22× · PMID 34716194 · DOI 10.1158/1078-0432.ccr-21-2480