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NCT00724841
A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma
Phase 1/Phase 2 trial testing Obatoclax Mesylate in Metastatic Melanoma in 1 participant. Terminated before completion.
1 July 2008
Quick facts
| Lead sponsor | Gemin X |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 1 June 2008 |
| Primary completion | 1 July 2008 |
| Estimated completion | 1 August 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Obatoclax Mesylate — full drug profile →
- Temozolomide (temozolomide) — full drug profile →
Conditions studied
- Metastatic Melanoma — all drugs for Metastatic Melanoma →
Sponsor
Gemin X — full company profile →
Who can join
18 and older, any sex, with Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
Time frame: 2 years -
Learn more about the side effects of taking GMX1777 in combination with temozolomide
Time frame: Within the first 4 weeks -
Determine the disease response to treatment with GMX1777 in combination with temozolomide
Time frame: Within the first 8 weeks
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Small Molecule NF-κB Pathway Inhibitors in Clinic.
Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164 -
Recent Advances in NAMPT Inhibitors: A Novel Immunotherapic Strategy.
Galli U, Colombo G, Travelli C, Tron GC, et al · · 2020 · cited 122× · PMID 32477131 · DOI 10.3389/fphar.2020.00656 -
Review of various NAMPT inhibitors for the treatment of cancer.
Wei Y, Xiang H, Zhang W. · · 2022 · cited 74× · PMID 36160449 · DOI 10.3389/fphar.2022.970553 -
Ionophores: Potential Use as Anticancer Drugs and Chemosensitizers.
Kaushik V, Yakisich JS, Kumar A, Azad N, et al · · 2018 · cited 58× · PMID 30262730 · DOI 10.3390/cancers10100360 -
Pancreatic neuroendocrine tumors: Therapeutic challenges and research limitations.
Mpilla GB, Philip PA, El-Rayes B, Azmi AS. · · 2020 · cited 46× · PMID 32821069 · DOI 10.3748/wjg.v26.i28.4036 -
NAMPT as a Dedifferentiation-Inducer Gene: NAD<sup>+</sup> as Core Axis for Glioma Cancer Stem-Like Cells Maintenance.
Lucena-Cacace A, Umeda M, Navas LE, Carnero A. · · 2019 · cited 36× · PMID 31119097 · DOI 10.3389/fonc.2019.00292 -
From Laboratory Studies to Clinical Trials: Temozolomide Use in IDH-Mutant Gliomas.
Sun X, Turcan S. · · 2021 · cited 31× · PMID 34067729 · DOI 10.3390/cells10051225 -
The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
Verify or expand the search:
- PubMed search for NCT00724841
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Melanoma
Currently open trials in the same condition.
- NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
- NCT07237100 — Mirdametinib in Patients With Advanced NF1-mutant Melanoma · Phase 2 · recruiting
- NCT07086105 — A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma · Phase 1 · recruiting
- NCT07112170 — Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma · NA · recruiting
- NCT06488365 — In Vivo Liquid Biopsy of Melanoma (Cytophone) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00724841 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gemin X
- Last refreshed: 20 July 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00724841.
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