Clinical trial · Interventional
Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas
A Single-Center, Open-Label, Phase I Study of Single-Agent GMX1777 Administered as a 24-Hour Infusion Every 3 Weeks to Patients With Refractory Solid Tumors or Lymphomas
NCT00457574CI-TRIAL-00011946withdrawnPhase 1ClinicalTrials.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 constraints.
Summary
Brief summary (as posted)
GMX1777 is a water-soluble, intravenously-administered prodrug 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 |
|---|---|---|---|
| Solid Tumors and Lymphomas | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GMX1777 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters
- timeFrame
- 52 weeks
Secondary outcomes (1)
- measure
- Describe observed tumor responses
- timeFrame
- 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a histologically or cytologically confirmed solid tumor or lymphoma * No limitations on allowable type and amount of prior therapy. * Patients must have a life expectancy of greater than 8 weeks * Patients must have normal organ and marrow function * Patients must be willing to submit blood sampling for planned PK analysis * Patients must have the ability to understand and willingness to sign a written informed consent form Exclusion Criteria: * No other agents or therapies administered with the intent to treat malignancy * Patients with prior exposure to GMX1777 or GMX1778 * Uncontrolled, intercurrent illness * Pregnant women and women who are breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.