NCT02658396

GO-203-2C + Bortezomib For Relapsed Or Refractory MM

A Phase I Trial of the MUC1 Inhibitor, GO-203-2c, in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a combination of targeted therapies known as GO-203-2C and bortezomib as a possible treatment for multiple myeloma that has either progressed or not responded to treatment.

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved GO-203-2C as a treatment for any disease. The FDA (the U.S. Food and Drug Administration) has approved bortezomib as a treatment option for your disease. The purpose of this research study is to test the safety of GO-203-2C with bortezomib. GO-203-2C is a newly discovered compound that binds to an oncoprotein (a cancer causing protein) called MUC1. Myeloma cells harbor an increased amount of MUC1 on its cell surface. By binding to MUC1, GO-203-2C has been shown to cause tumor cell death in laboratory studies. Bortezomib is an intravenously or subcutaneously administered medication that belongs to a class of drugs called proteasome inhibitors. Proteasome inhibitors disrupt the normal action of cells that breakdown proteins in both normal and cancer cells. This disruption can stall tumor growth and cause cancer cells to die. Bortezomib is currently approved for the treatment of multiple myeloma. The Investigators want to find the highest dose of GO-203-2C given in combination with bortezomib that can be administered safely without severe or unmanageable side effects.

Conditions

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	GO-203-2C
DRUG	Bortezomib

Timeline

• Primary completion: 2019-05-01
• Completion: 2022-01-01
• First posted: 2016-01-18
• Last updated: 2017-07-05

Locations

2 sites across 1 country: United States