NCT03802084

A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced Desmoid Tumor

Completed Phase 1, PHASE2 Last updated 13 May 2024

What this trial tests

Phase 1, PHASE2 trial testing vactosertib/imatinib combination in Desmoid Tumor in 24 participants. Completed in 26 March 2024.

Timeline

15 April 2019

Primary endpoint
26 March 2024

26 March 2024

Quick facts

Lead sponsor	Hyo Song Kim
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	15 April 2019
Primary completion	26 March 2024
Estimated completion	26 March 2024
Sites	1 location across South Korea

Drugs / interventions tested

• vactosertib/imatinib combination — full drug profile →

Conditions studied

• Desmoid Tumor — all drugs for Desmoid Tumor →

Sponsor

Hyo Song Kim — full company profile →

Who can join

19 and older, any sex, with Desmoid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I/II, open-label, non-randomized, multicentre study to evaluate the clinical activity of vactosertib plus imatinib in desmoid tumor. Based on the background, TGF-β inhibition as a potential therapeutic target for desmoid tumor and convey significant implications for the clinical development. Therefore, investigator will conduct the phase II trial of vactosertib in combined with imatinib in desmoid tumor.

Publications & conference data

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

1. TGF-β signaling in health, disease, and therapeutics.
   Deng Z, Fan T, Xiao C, Tian H, et al · · 2024 · cited 737× · PMID 38514615 · DOI 10.1038/s41392-024-01764-w
2. Novel therapies emerging in oncology to target the TGF-β pathway.
   Kim BG, Malek E, Choi SH, Ignatz-Hoover JJ, et al · · 2021 · cited 336× · PMID 33823905 · DOI 10.1186/s13045-021-01053-x
3. Targeting TGFβ signal transduction for cancer therapy.
   Liu S, Ren J, Ten Dijke P. · · 2021 · cited 302× · PMID 33414388 · DOI 10.1038/s41392-020-00436-9
4. Therapeutic Targets for the Treatment of Cardiac Fibrosis and Cancer: Focusing on TGF-β Signaling.
   Parichatikanond W, Luangmonkong T, Mangmool S, Kurose H. · · 2020 · cited 118× · PMID 32211422 · DOI 10.3389/fcvm.2020.00034
5. TGF-beta signal transduction: biology, function and therapy for diseases.
   Tie Y, Tang F, Peng D, Zhang Y, et al · · 2022 · cited 97× · PMID 36534225 · DOI 10.1186/s43556-022-00109-9
6. Regulation and signaling pathways in cancer stem cells: implications for targeted therapy for cancer.
   Zeng Z, Fu M, Hu Y, Wei Y, et al · · 2023 · cited 93× · PMID 37853437 · DOI 10.1186/s12943-023-01877-w
7. Cancer-associated fibroblasts as therapeutic targets for cancer: advances, challenges, and future prospects.
   Cao Z, Quazi S, Arora S, Osellame LD, et al · · 2025 · cited 57× · PMID 39780187 · DOI 10.1186/s12929-024-01099-2
8. Evolving strategies for management of desmoid tumor.
   Riedel RF, Agulnik M. · · 2022 · cited 52× · PMID 35670122 · DOI 10.1002/cncr.34332