Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas
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ClinicalTrials.gov Identifier: NCT00457574
(Study terminated prematurely due to financial constraints.)
GMX1777 is a water-soluble, intravenously-administered prodrug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.
Condition or disease
Solid Tumors and Lymphomas
This is a single-center, open-label, Phase I study of single-agent GMX1777 administered every 3 weeks to patients with CLL, MM, refractory solid tumors or lymphomas. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have a histologically or cytologically confirmed solid tumor or lymphoma
No limitations on allowable type and amount of prior therapy.
Patients must have a life expectancy of greater than 8 weeks
Patients must have normal organ and marrow function
Patients must be willing to submit blood sampling for planned PK analysis
Patients must have the ability to understand and willingness to sign a written informed consent form
No other agents or therapies administered with the intent to treat malignancy
Patients with prior exposure to GMX1777 or GMX1778