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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Solid Tumors and Lymphomas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GMX1777

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Berger, MD

Role: STUDY_DIRECTOR

Gemin X, Inc.

Countries

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United States

Other Identifiers

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GEM301

Identifier Type: -

Identifier Source: org_study_id