Status:
WITHDRAWN
Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Celgene
GlaxoSmithKline
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 patien...
Detailed Description
While treatment for melanoma has evolved in the last few years, advanced/metastatic melanoma remains an aggressive disease with poor prognosis. Trametinib and nab-paclitaxel have demonstrated single-a...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02300935
Start Date
December 1 2015
End Date
January 20 2016
Last Update
May 30 2019
Active Locations (3)
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1
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
2
Florida Cancer Center
Sarasota, Florida, United States, 34232
3
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203