Clinical trial · Interventional
Use of 852A in Metastatic Cutaneous Melanoma.
Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.
NCT00189332CI-TRIAL-00001753completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Unresectable Metatstatic Cutaneous Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 852A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks
Secondary outcomes (2)
- measure
- to assess the safety of the dosage regiment over 12 weeks
- measure
- to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced melanoma not responding to 1st line chemotherapy * Histological evidence of melanoma * Measurable disease according to RECIST criteria * ECOG performance status less than or equal to 2 * Life expectancy 6 months or more * Normal organ and bone marrow function as defined by hematological and serum chemistry limits * Adequate contraception for females of childbearing potential Exclusion Criteria: * Stage IV disease which has previously progressed during interferon treatment. * Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes * History of uncontrolled seizure disorders * Uncontrolled coagulation disorders. * History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months * History of uncontrolled intercurrent or chronic illness * Concurrent malignancies. * Brain metastases. * HIV positive. * Prolonged QTc interval * Uncontrolled intercurrent or chronic illnesses. * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.