Status:
WITHDRAWN
Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas
Lead Sponsor:
Gemin X
Conditions:
Solid Tumors and Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 m...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- No other agents or therapies administered with the intent to treat malignancy
- Patients with prior exposure to GMX1777 or GMX1778
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00457574
Start Date
March 1 2007
End Date
August 1 2010
Last Update
August 28 2013
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