Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas

• Status: Withdrawn
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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 models from different tumor origins.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gemin X

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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