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

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00724841

Enrollment

Registered

2008-07-30

Start date

2008-06-30

Completion date

2010-08-31

Last updated

2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Melanoma

Brief 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.

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.

Interventions

DRUGObatoclax Mesylate

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

DRUGTemozolomide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Learn more about how the body processes GMX1777	Within the fisrt 30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026