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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.
Full 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.
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Inclusion criteria
Participants with multiple myeloma who experienced disease progression after the most recent treatment regimen. Patients must have had prior treatment with a proteasome inhibitor, immunomodulatory drug, and if eligible for transplant an autologous transplant.
Patients must have measurable disease, defined as 1 or more of the following:
Greater than or equal to 18 years in age
ECOG performance status ≤2 (see Appendix A)
Life expectancy of greater than 3 months
Participants must have normal organ and marrow function as defined below:
leukocytes ≥2,000/mcL
platelets ≥50,000/mcL
total bilirubin ≤ 2.0 mg/dL (patients with Gilbert syndrome and Bilirubin ≤ 3.5 mg/dL are eligible)
AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
creatinine ≤ 2 mg/dL
--- OR
creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
Women of child-bearing potential must have a documented negative pregnancy test.
The effects of GO-203-2c on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of GO-203-2c administration.
Ability to understand and the willingness to sign a written informed consent document
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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