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Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma

A Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined With Chemotherapy in Advanced Soft Tissue and Bone Sarcomas

NCT05116800•Brown University

View on ClinicalTrials.gov

Summary

This is an open label, two-stratum, phase 2 clinical trial evaluating the efficacy of 9-ING-41 in combination with gemcitabine/docetaxel in patients ≥10 years of age with advanced sarcoma. 9-ING-41 in combination with gemcitabine and docetaxel will lead to sustained disease control and/or increase the rates of objective response in patients with unresectable or metastatic soft tissue and bone sarcomas.

Eligibility

Age

10 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Stratum A: Patients must have histologically confirmed grade 2 or 3 soft tissue sarcoma that is locally advanced and unresectable, or metastatic, consisting of one of the following subtypes: undifferentiated pleomorphic sarcoma (malignant fibrous histiocytoma), myxofibrosarcoma, leiomyosarcoma, liposarcoma (excluding well-differentiated), angiosarcoma, synovial sarcoma, rhabdomyosarcoma, spindle cell sarcoma and high-grade sarcoma NOS.
•Stratum B: Patients must have histologically confirmed bone sarcoma that is relapsed or refractory following front-line therapy consisting of one of the following subtypes: osteosarcoma and Ewing sarcoma.
•Patients must have at least one site of measurable disease by RECIST 1.1. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
•Stratum A: No more than three prior lines of systemic therapy. Of note, anthracycline-based chemotherapy is generally considered first-line therapy. Previously untreated patients may be enrolled at the discretion of the treating investigator.
•Stratum B: At least one prior line of systemic therapy.
•Age ≥10 years.
•Lansky score ≥50 for patients \<16 years or ECOG performance status ≤2 for patients ≥16 years (Karnofsky ≥50%, see Appendix A).
•Life expectancy of greater than 12 weeks.
•Patients must have adequate organ and marrow function as defined below:
•* Hemoglobin ≥8 g/dl
+19 more criteria

Exclusion Criteria

•Patients with sarcoma histologies other than those listed above will be excluded.
•Prior treatment with 9-ING-41, gemcitabine, or docetaxel.
•Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
•Patients who are receiving any other investigational agents for treatment of their sarcoma.
•Patients who are pregnant or lactating.
•Patients with untreated brain or meningeal metastases. Subjects with history of metastases are eligible provided they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 14 days after definitive therapy.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to 9-ING-41, gemcitabine, docetaxel, or other agents used in study.
•Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Has had a previous (within 2 years) or has a current malignancy other than the target cancer with the exception of curatively treated local tumors including carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade \< 6 and prostate-specific antigen within normal range.
•Has any medical and/or social condition that, in the opinion of the investigator would preclude study participation.

Locations (2)

Hasbro Children's Hospital

Providence, Rhode Island, United States

Lifespan Cancer Insitute

Providence, Rhode Island, United States

Key Dates

Start Date

March 1, 2022

Primary Completion Date

August 1, 2025

Completion Date

August 1, 2030

Last Updated

December 7, 2021

Conditions

Soft Tissue SarcomaUndifferentiated Pleomorphic SarcomaMyxofibrosarcomaLeiomyosarcomaLiposarcomaAngiosarcomaSynovial SarcomaRhabdomyosarcomaSpindle Cell SarcomaHigh Grade SarcomaBone SarcomaOsteosarcomaEwing Sarcoma of Bone

Interventions

Gemcitabine

DRUG

9-ING-41

DRUG

Docetaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma

Inclusion Criteria

Exclusion Criteria

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