Overview

Study of Trametinib and Nab-paclitaxel in Patients With Melanoma

Status:
Withdrawn
Trial end date:
2016-01-20
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborators:
Celgene
Celgene Corporation
GlaxoSmithKline
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Trametinib
Criteria
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 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)