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Study of Trametinib and Nab-paclitaxel in Patients With Melanoma

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ClinicalTrials.gov Identifier: NCT02300935
Recruitment Status : Withdrawn (Study concept was terminated.)
First Posted : November 25, 2014
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
Celgene
GlaxoSmithKline
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

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 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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: trametinib Drug: nab-paclitaxel Phase 1

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-agent activity in Phase III trials of patients with melanoma. The investigators propose to investigate this drug combination in patients with advanced unresectable or metastatic melanoma. This open-label Phase I study is designed to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D), and safety profile of trametinib and nab-paclitaxel given in combination. Patients with melanoma and known BRAF mutation status will receive escalating doses of trametinib and nab-paclitaxel to determine the MTD. Once the MTD is determined an additional 6 patients will be treated at the MTD to establish the dose for future studies.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
Estimated Study Start Date : December 2015
Actual Primary Completion Date : January 20, 2016
Actual Study Completion Date : January 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: trametinib and nab-paclitaxel
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.
Drug: trametinib
Other Name: Mekinist

Drug: nab-paclitaxel
Other Name: Abraxane




Primary Outcome Measures :
  1. Number of patients with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: weekly for the first 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300935


Locations
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United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Center
Sarasota, Florida, United States, 34232
United States, Tennessee
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
SCRI Development Innovations, LLC
Celgene
GlaxoSmithKline
Investigators
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Study Chair: Jeffrey R. Infante, MD SCRI Development Innovations, LLC

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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT02300935     History of Changes
Other Study ID Numbers: SCRI MEL 40
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

Keywords provided by SCRI Development Innovations, LLC:
trametinib
nab-paclitaxel
Mekinist
Abraxane
unresectable
metastatic

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Paclitaxel
Albumin-Bound Paclitaxel
Trametinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors