Clinical trial · Interventional
Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
- 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)
This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.
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 |
| Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABI-007 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
Secondary outcomes (1)
- measure
- Evaluate number of cycles required before patients achieve maximum response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed Metastatic Melanoma * At least 18 years old * No other active malignancy * Hemoglobin at least 9 * Platelet Count at least 100,000 cells/mm3 * ANC at least 1500 cells/mm3 * AST \& ALT less than 2.5X upper limit of normal * Total bilirubin less than 1.5mg/dL * Creatine less than 1.5 mg/dL * Alkaline phosphatase less than 2.5X upper limit of normal * Life expectancy of at least 12 weeks * ECOG performance status of 0-1 * Patient must provide informed consent * Patient must provide authorization to disclose Exclusion Criteria: * Evidence of active brain metastases * The only evidence of metastasis is lytic or blastic bone metastases * Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2 * Received radiotherapy in last 4wks, except if to a non-target lesion only * Clinically significant concurrent illness * Investigator's opinion that patient unlikely to complete study * Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks * History of allergy/hypersensitivity to study drug * Serious Medical Risk Factors determine by the investigator
References
Publications (0)
Data not yet available