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

Primary Purpose

Solid Tumors and Lymphomas

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

GMX1777

About this trial

This is an interventional treatment trial for Solid Tumors and Lymphomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters

Secondary Outcome Measures

Describe observed tumor responses

Full Information

NCT ID

NCT00457574

First Posted

April 5, 2007

Last Updated

August 27, 2013

Sponsor

Gemin X

1. Study Identification

Unique Protocol Identification Number

NCT00457574

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Study terminated prematurely due to financial constraints.

Study Start Date

March 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gemin X

4. Oversight

Data Monitoring Committee

5. Study Description

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 models from different tumor origins.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solid Tumors and Lymphomas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

GMX1777

Primary Outcome Measure Information:

Title

Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Describe observed tumor responses

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Berger, MD

Organizational Affiliation

Gemin X, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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