NCT03670069 is a Phase 1 clinical trial of Itacitinib in Metastatic Leiomyosarcoma, sponsored by Fred Hutchinson Cancer Center.

Who is sponsoring NCT03670069?

NCT03670069 is sponsored by Fred Hutchinson Cancer Center.

What drugs are being tested in NCT03670069?

Interventions in NCT03670069: Itacitinib, Laboratory Biomarker Analysis.

What condition does NCT03670069 study?

NCT03670069 studies Metastatic Leiomyosarcoma, Metastatic Synovial Sarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Advanced Myxoid Liposarcoma, Advanced Soft Tissue Sarcoma, Metastatic Myxoid Liposarcoma, Metastatic Round Cell Liposarcoma, Metastatic Soft Tissue Sarcoma, Refractory Leiomyosarcoma, Refractory Myxoid Liposarcoma, Refractory Round Cell Liposarcoma, Refractory Soft Tissue Sarcoma, Refractory Synovial Sarcoma, Refractory Undifferentiated Pleomorphic Sarcoma, Advanced Leiomyosarcoma, Advanced Synovial Sarcoma, Advanced Undifferentiated Pleomorphic Sarcoma, Metastatic Chondrosarcoma.

Is NCT03670069 still recruiting?

NCT03670069 is currently terminated. Last updated 8 May 2024.

Last reviewed 2024-05-08 · How we verify

NCT03670069

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas

Terminated Phase 1 Last updated 8 May 2024

What this trial tests

Phase 1 trial testing Itacitinib in Metastatic Leiomyosarcoma in 27 participants. Terminated before completion.

Timeline

30 September 2019

Primary endpoint
4 March 2023

6 May 2024

Quick facts

Lead sponsor	Fred Hutchinson Cancer Center
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	30 September 2019
Primary completion	4 March 2023
Estimated completion	6 May 2024
Sites	1 location across United States

Drugs / interventions tested

Itacitinib — full drug profile →
Laboratory Biomarker Analysis — full drug profile →

Conditions studied

Metastatic Leiomyosarcoma — all drugs for Metastatic Leiomyosarcoma →
Metastatic Synovial Sarcoma — all drugs for Metastatic Synovial Sarcoma →
Metastatic Undifferentiated Pleomorphic Sarcoma — all drugs for Metastatic Undifferentiated Pleomorphic Sarcoma →
Advanced Myxoid Liposarcoma — all drugs for Advanced Myxoid Liposarcoma →

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Metastatic Leiomyosarcoma or Metastatic Synovial Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot phase I trial studies how well itacitinib works in treating patients with sarcomas that do not respond to treatment (refractory) and have spread to other parts of the body (advanced/metastatic). Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

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

JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
STAT proteins: a kaleidoscope of canonical and non-canonical functions in immunity and cancer.
Awasthi N, Liongue C, Ward AC. · · 2021 · cited 97× · PMID 34809691 · DOI 10.1186/s13045-021-01214-y
JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
Targeting the JAK/STAT pathway in solid tumors.
Qureshy Z, Johnson DE, Grandis JR. · · 2020 · cited 76× · PMID 33521321 · DOI 10.20517/2394-4722.2020.58
Pro-Inflammatory Cytokines in the Formation of the Pre-Metastatic Niche.
Li R, Wen A, Lin J. · · 2020 · cited 63× · PMID 33322216 · DOI 10.3390/cancers12123752
Chondrosarcoma-from Molecular Pathology to Novel Therapies.
Zając AE, Kopeć S, Szostakowski B, Spałek MJ, et al · · 2021 · cited 56× · PMID 34069269 · DOI 10.3390/cancers13102390
Liposarcoma: Advances in Cellular and Molecular Genetics Alterations and Corresponding Clinical Treatment.
Yang L, Chen S, Luo P, Yan W, et al · · 2020 · cited 40× · PMID 31892977 · DOI 10.7150/jca.36380

Verify or expand the search:

Other trials of Itacitinib

Trials testing the same drug.

NCT05660421 — Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors · Phase 2 · withdrawn
NCT05364762 — Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergo · Phase 2 · active not recruiting
NCT05063110 — Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB · Phase 2 · completed
NCT04859946 — Itacitinib for the Prevention of Graft Versus Host Disease · Phase 2 · active not recruiting
NCT04239989 — Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant · Phase 1 · terminated

Other recruiting trials for Metastatic Leiomyosarcoma

Currently open trials in the same condition.

NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis · Phase 1, PHASE2 · recruiting
NCT06571734 — XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma · Phase 2 · recruiting
NCT05711615 — Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Adv · Phase 1 · recruiting
NCT04200443 — Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcom · Phase 2 · active not recruiting

Other Fred Hutchinson Cancer Center trials

Trials by the same sponsor.

NCT07390968 — Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Pati · Phase 2 · not yet recruiting
NCT07493252 — A Behavioral Application for Improving Smoking Cessation Among Smokers · NA · not yet recruiting
NCT07490860 — A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to · NA · not yet recruiting
NCT07194980 — Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small L · Phase 2 · not yet recruiting
NCT07176000 — Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington S · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03670069 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Center
Last refreshed: 8 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03670069.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing