NCT02300935

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2016

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

November 21, 2014

Last Update Submit

May 28, 2019

Conditions

Melanoma

Keywords

trametinibnab-paclitaxelMekinistAbraxaneunresectablemetastatic

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Adverse Events (AEs) as a Measure of Safety and Tolerability

    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.

    weekly for the first 4 weeks

Study Arms (1)

trametinib and nab-paclitaxel

EXPERIMENTAL

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: trametinibDrug: nab-paclitaxel

Interventions

trametinibDRUG
Also known as: Mekinist
trametinib and nab-paclitaxel
nab-paclitaxelDRUG
Also known as: Abraxane
trametinib and nab-paclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Florida Cancer Center

Sarasota, Florida, 34232, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Interventions

trametinib130-nm albumin-bound paclitaxelAlbumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Jeffrey R. Infante, MD

    SCRI Development Innovations, LLC

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2014

First Posted

November 25, 2014

Study Start

December 1, 2015

Primary Completion

January 20, 2016

Study Completion

January 20, 2016

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

US(3)