Clinical trial · Interventional
Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
Phase I Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
- 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 concept was terminated.
Summary
Brief summary (as posted)
This study will investigate the combination of two drugs, trametinib and nab-paclitaxel, in patients with advanced unresectable or metastatic melanoma. Each drug has shown activity in trials of patients with melanoma. However, the combination of these two drugs has not been studied. In this trial the investigators will determine the maximum dose of the drug combination to be administered to patients with advanced unresectable or metastatic melanoma and examine the safety profile of the drug combination.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- trametinib and nab-paclitaxel
- description
- Trametinib will be dosed at 1mg, 1.5mg, and 2mg orally (PO) daily based on Phase I data of this drug as a single agent. All patients entering this study will receive intravenous (IV) nab-paclitaxel on Day 1, 8, and 15. Dose levels will be assigned to each patient, and dose escalation decisions will be based on the evaluation of safety data from the prior cohort.
- interventionNames
- Drug: trametinib
- Drug: nab-paclitaxel
Primary outcomes (1)
- measure
- Number of patients with Adverse Events (AEs) as a Measure of Safety and Tolerability
- timeFrame
- weekly for the first 4 weeks
- description
- The maximum tolerated dose (MTD) of the drug combination will be determined as the highest dose at which ≤1 of 6 patients experience a dose limiting toxicity (DLT) during one cycle (28 days) of therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (≥18 years) with histologically or cytologically-confirmed advanced unresectable or metastatic melanoma. BRAF mutation-positive and wild-type tumors are allowed. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic, renal, and hepatic function * Life expectancy ≥12 weeks * Any pre-existing neuropathy must be \<grade 2 per Common Technology Criteria for Adverse Events (CTCAE) version 4.0 Exclusion Criteria: * More than 1 prior cytotoxic chemotherapy regimen in the metastatic setting * Prior MEK inhibitor therapy (prior BRAF inhibitor allowed) * Prior nab-paclitaxel (prior taxane allowed) * Use of an investigational anti-cancer drug within 21 days or 5 half-lives (whichever is shorter) prior to first dose. A minimum of 10 days after termination of investigational drug is required. Any drug-related toxicity should have resolved to Grade 1 or baseline. * Symptomatic or untreated brain metastases * History of retinal vein occlusion (RVO)
References
Publications (0)
Data not yet available