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

Metastatic Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00724841
• Other study ID #: GEM303
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 28, 2008
• Last updated: July 20, 2016
• Start date: June 2008
• Est. completion date: August 2010

Study information

• Verified date: July 2016
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Obatoclax Mesylate
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
• Temozolomide

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the recommended Phase II dose of GMX1777 in combination with temozolomide		2 years	No
Primary	Learn more about the side effects of taking GMX1777 in combination with temozolomide		Within the first 4 weeks	Yes
Primary	Determine the disease response to treatment with GMX1777 in combination with temozolomide		Within the first 8 weeks	No
Secondary	Learn more about how the body processes GMX1777		Within the fisrt 30 days	No