Safety and Efficacy of GMX1777 in the Treatment of Refrac... | NCT00457574

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

NCT00457574

Sponsor

Gemin X

Status

Withdrawn

Last Update Posted

Aug 28, 2013Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Solid Tumors and Lymphomas

Interventions

GMX1777

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated prematurely due to financial constraints.

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Jul 2009Actual

Completion Date

Aug 2010Actual

First Submitted Date

Apr 5, 2007

First Submission Date that Met QC Criteria

Apr 5, 2007

First Posted Date

Apr 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2013

Last Update Posted Date

Aug 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
GMX1777	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters		52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Describe observed tumor responses		52 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mark Berger, MD	Gemin X, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C541789	1-(2-(2-(2-(2-methoxyethoxy)ethoxy)ethoxy)ethoxycarbonyloxymethyl)-4-(N'-cyano-N''-(6-(4-chlorophenoxy)hexyl)-N-guanidino)pyridinium

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided