Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma (NCT05116800) | Clinical Trial Compass
WithdrawnPhase 2
Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma
Stopped: IND withdrawn
United States0Started 2022-03-01
Plain-language 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.
Who can participate
Age range10 Years
SexALL
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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
* absolute neutrophil count ≥1,000/mcL
* platelets ≥100,000/mcL (transfusion …