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

Solid Tumors and Lymphomas Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00457574
• Other study ID #: GEM301
• Status: Withdrawn
• Phase: Phase 1
• First received: April 5, 2007
• Last updated: August 27, 2013
• Start date: March 2007
• Est. completion date: August 2010

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumors and Lymphomas

Intervention

Drug:
• GMX1777

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters		52 weeks	No
Secondary	Describe observed tumor responses		52 weeks	No