Clinical trial · Interventional
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
NCT00724841CI-TRIAL-00023202terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated prematurely due to financial contraints.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obatoclax Mesylate | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- 1
- description
- 40 mg/m2 GMX1777 with Temozolomide
- interventionNames
- Drug: Obatoclax Mesylate
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- 2
- description
- 50 mg/m2 GMX1777 with Temozolomide
- interventionNames
- Drug: Obatoclax Mesylate
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- 3
- description
- 62 mg/m2 GMX1777 with Temozolomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.