NCT00457574

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2007

Typical duration for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

2.3 years

First QC Date

April 5, 2007

Last Update Submit

August 27, 2013

Conditions

Solid Tumors and Lymphomas

Outcome Measures

Primary Outcomes (1)

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

    52 weeks

Secondary Outcomes (1)

  • Describe observed tumor responses

    52 weeks

Interventions

GMX1777DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma

Interventions

1-(2-(2-(2-(2-methoxyethoxy)ethoxy)ethoxy)ethoxycarbonyloxymethyl)-4-(N'-cyano-N''-(6-(4-chlorophenoxy)hexyl)-N-guanidino)pyridinium

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Mark Berger, MD

    Gemin X, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2007

First Posted

April 6, 2007

Study Start

March 1, 2007

Primary Completion

July 1, 2009

Study Completion

August 1, 2010

Last Updated

August 28, 2013

Record last verified: 2013-08