A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma

July 20, 2016 updated by: Gemin X

A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma

Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic melanoma
  • Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed
  • Normal organ and marrow function
  • Willing to submit to blood sampling for planned PK/PD analyses
  • Ability of understand and willingness to sign a written informed consent

Exclusion Criteria:

  • No other investigational or commercial agents or therapies
  • Prior exposure to GMX1777, GMX1778 or CHS828
  • Patients with uncontrolled, intercurrent illness
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
40 mg/m2 GMX1777 with Temozolomide
Drug: Temozolomide
Drug: Obatoclax Mesylate
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
Other Names:
  • GMX1777
EXPERIMENTAL: 2
50 mg/m2 GMX1777 with Temozolomide
Drug: Temozolomide
Drug: Obatoclax Mesylate
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
Other Names:
  • GMX1777
EXPERIMENTAL: 3
62 mg/m2 GMX1777 with Temozolomide
Drug: Temozolomide
Drug: Obatoclax Mesylate
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
Other Names:
  • GMX1777
EXPERIMENTAL: 4
80 mg/m2 GMX1777 with Temozolomide
Drug: Temozolomide
Drug: Obatoclax Mesylate
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
Other Names:
  • GMX1777
EXPERIMENTAL: 5
100 mg/m2 GMX1777 with Temozolomide
Drug: Temozolomide
Drug: Obatoclax Mesylate
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
Other Names:
  • GMX1777
EXPERIMENTAL: 6
125 mg/m2 GMX1777 with Temozolomide
Drug: Temozolomide
Drug: Obatoclax Mesylate
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
Other Names:
  • GMX1777

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
Time Frame: 2 years
2 years
Learn more about the side effects of taking GMX1777 in combination with temozolomide
Time Frame: Within the first 4 weeks
Within the first 4 weeks
Determine the disease response to treatment with GMX1777 in combination with temozolomide
Time Frame: Within the first 8 weeks
Within the first 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Learn more about how the body processes GMX1777
Time Frame: Within the fisrt 30 days
Within the fisrt 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gemin X

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (ESTIMATE)

July 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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