Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
Withdrawn before enrolling · Phase 1
Conditions studied: Melanoma
In brief
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.
Key facts
- Study ID
- NCT02300935
- Run by
- SCRI Development Innovations, LLC
- People needed
- 0
- Starts
- 2015-12-01
- Expected to finish
- 2016-01-20
- Last updated by the study team
- 2019-05-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- Florida Cancer Center — Sarasota, Florida, United States
- Tennessee Oncology PLLC — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.