NCT04906876

A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas

A Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined With Chemotherapy in Adolescents and Adults With Advanced 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• Status: Withdrawn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

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. 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. Stratum A: Patients with advanced soft tissue sarcoma previously treated with 0-3 prior lines of systemic therapy will receive 9-ING-41 twice weekly with gemcitabine on days 1 and 8 and docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity. Stratum B: Patients with relapsed or refractory bone sarcoma previously treated with at least one line of systemic therapy will receive 9-ING-41 twice weekly with gemcitabine on days 1 and 8 and docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity. Disease response assessment will be performed every 2 cycles (6 weeks) for the first 8 cycles (24 weeks), then every 12 weeks thereafter.

Conditions

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

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine as a 90-minute IV infusion
DRUG	Docetaxel	Docetaxel as a 60-minute IV infusion
DRUG	9-ING-41	9-ING-41 as an IV infusion over 1-4 hours twice weekly

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-07-01
• Completion: 2025-07-01
• First posted: 2021-05-28
• Last updated: 2021-07-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study