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TerminatedNCT00724841Updated Jul 22, 2016

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

A Phase 1/2 interventional study of Obatoclax Mesylate and Temozolomide in Metastatic Melanoma, sponsored by Gemin X. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-22.

Sponsored by Gemin X · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Study terminated prematurely due to financial contraints.
Phase
Phase 1/2
Study type
Interventional
Enrollment
1
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Metastatic Melanoma

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03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 1 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Gemin X is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    1

    40 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate · Drug: Temozolomide

  • Experimental
    2

    50 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate · Drug: Temozolomide

  • Experimental
    3

    62 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate · Drug: Temozolomide

  • Experimental
    4

    80 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate · Drug: Temozolomide

  • Experimental
    5

    100 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate · Drug: Temozolomide

  • Experimental
    6

    125 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate · Drug: Temozolomide

Interventions

  • DrugObatoclax Mesylate

    Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide

    Also known as: GMX1777

  • DrugTemozolomide
06

What researchers measure

Primary outcomes

  1. Determine the recommended Phase II dose of GMX1777 in combination with temozolomide

    Time frame: 2 years

  2. Learn more about the side effects of taking GMX1777 in combination with temozolomide

    Time frame: Within the first 4 weeks

  3. Determine the disease response to treatment with GMX1777 in combination with temozolomide

    Time frame: Within the first 8 weeks

Secondary outcomes

  1. Learn more about how the body processes GMX1777

    Time frame: Within the fisrt 30 days

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00724841
Lead sponsor
Gemin X
Responsible party
Sponsor
First posted
Jul 30, 2008
Start date
Jun 2008
Primary completion
Jul 2008
Completion
Aug 2010
Last update
Jul 22, 2016

Study contacts

Mark Berger, MD
study director · Gemin X, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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