GO-203-2C + Bortezomib For Relapsed Or Refractory MM
|ClinicalTrials.gov Identifier: NCT02658396|
Recruitment Status : Withdrawn (Study was never open due to lack of funding)
First Posted : January 18, 2016
Last Update Posted : July 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Multiple Myeloma in Relapse Refractory Multiple Myeloma||Drug: GO-203-2C Drug: Bortezomib||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of the MUC1 Inhibitor, GO-203-2c, in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||January 2022|
The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma, not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated.
Other Name: Velcade
- MTD Dose [ Time Frame: Baseline to 21 Days ]
- Response Rate [ Time Frame: 12 Months ]
- Progression Free Survival [ Time Frame: Start of treatment to disease progression or death from any cause, assessed up to 100 months ]Estimated using the method of Kaplan and Meier.
- Event Free Survival [ Time Frame: Time of treatment initiation to Progressive Disease, death, or nonprotocol therapy, assessed up to 100 months ]Estimated using the method of Kaplan and Meier.
- Time-to-new treatment [ Time Frame: From treatment initiation to next treatment or death of any cause, assessed up to 100 months ]Estimated using the method of Kaplan and Meier.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658396
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jacalyn Rosenblatt, MD||Beth Israel Deaconess Medical Center|