Clinical trial · Interventional
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
A Phase 2 Study Of Weekly Infusion Nab-paclitaxel (Paclitaxel Protein-bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal 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)
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.
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 |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel
- description
- Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
- interventionNames
- Drug: nab-paclitaxel
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- up to 1 year following last treatment, for a total of approximately 5 years
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary outcomes (2)
- measure
- Progression-free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed evidence of metastatic/ unresectable uveal melanoma * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension and is ≥10 mm by spiral CT scan * 18 years or older * Eastern Cooperative Oncology Group(ECOG)performance status 0, or 1 * No known HIV or Hepatitis B or C * Patients with brain metastasis are eligible for entry into the study * Patients must have normal organ/marrow function as defined below: * Absolute neutrophil count ≥ 1.5 x 109/L * Platelets ≥ 100,000 x 109/L * Hemoglobin ≥ 9.0 gm/100 ml * Total bilirubin ≤ 1.5. In patients with Gilbert's disease the indirect bilirubin must be less than or equal to 4.0. * AST and ALT ≤ 2.5x upper limit of normal * Alkaline phosphatase ≤ 2.5x upper limit of normal, unless bone metastases is present in the absence of liver metastasis * Creatinine ≤ 1.8 mg/ml or calculated creatinine clearance \> 50 mg ml. * Calcium \<12 mg/dl when corrected for levels of serum albumen * Patients my have had up to one prior systemic therapy Exclusion Criteria: * Chemotherapy or radiotherapy within 4 weeks prior to entering the study or failure to recover from adverse events due to agents administered more than 4 weeks earlier. * May not be receiving any other simultaneous investigational agents * No prior malignancy except for adequately treated basal cell cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years. * Patients who have serious infections or other major uncontrolled medical illnesses. * Patients who have significant psychiatric illness who in the opinion of the principal investigator would prevent adequate informed consent or render therapy unsafe. * Patients who are pregnant. Female patients of child bearing potential must have a negative serum pregnancy test and use adequate contraception protection while on study. * Peripheral neuropathy of \> grade 2.
References
Publications (0)
Data not yet available