Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Center, Open-Label, Phase I Study of Single-Agent GMX1777 Administered as a 24-Hour Infusion Every 3 Weeks to Patients With Refractory Solid Tumors or Lymphomas|
- Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Describe observed tumor responses [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457574
|Study Director:||Mark Berger, MD||Gemin X, Inc.|