NCT05116800

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Sarcoma
• Undifferentiated Pleomorphic Sarcoma
• Myxofibrosarcoma
• Leiomyosarcoma
• Liposarcoma
• Angiosarcoma
• Synovial Sarcoma
• Rhabdomyosarcoma
• Spindle Cell Sarcoma
• High Grade Sarcoma
• Bone Sarcoma
• Osteosarcoma
• Ewing Sarcoma of Bone

Interventions

Type	Name	Description
DRUG	Gemcitabine	Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
DRUG	9-ING-41	Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
DRUG	Docetaxel	Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-08-01
• Completion: 2030-08-01
• First posted: 2021-11-11
• Last updated: 2021-12-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study