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

Phase 1

Terminated

• Conditions: Metastatic Melanoma
• Interventions: Drug: Obatoclax Mesylate; Drug: Temozolomide

• Registration Number: NCT00724841
• Lead Sponsor: Gemin X

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.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-07
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-30
• Study Completion: 2010-08
• Disposition First Submitted: 2013-08-28
• Disposition First Submitted QC: 2013-08-28
• Disposition First Posted: 2013-09-13
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4	Temozolomide	80 mg/m2 GMX1777 with Temozolomide
2	Temozolomide	50 mg/m2 GMX1777 with Temozolomide
3	Obatoclax Mesylate	62 mg/m2 GMX1777 with Temozolomide
3	Temozolomide	62 mg/m2 GMX1777 with Temozolomide
4	Obatoclax Mesylate	80 mg/m2 GMX1777 with Temozolomide
1	Obatoclax Mesylate	40 mg/m2 GMX1777 with Temozolomide
2	Obatoclax Mesylate	50 mg/m2 GMX1777 with Temozolomide
5	Obatoclax Mesylate	100 mg/m2 GMX1777 with Temozolomide
6	Obatoclax Mesylate	125 mg/m2 GMX1777 with Temozolomide
1	Temozolomide	40 mg/m2 GMX1777 with Temozolomide
6	Temozolomide	125 mg/m2 GMX1777 with Temozolomide
5	Temozolomide	100 mg/m2 GMX1777 with Temozolomide

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Learn more about how the body processes GMX1777	Within the fisrt 30 days

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States