Back to resultsStudy of Trametinib and Nab-paclitaxel in Patients With Melanoma
Primary Purpose
Melanoma
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
trametinib
nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring trametinib, nab-paclitaxel, Mekinist, Abraxane, unresectable, metastatic
Eligibility 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)
Sites / Locations
- Colorado Blood Cancer Institute
- Florida Cancer Center
- Tennessee Oncology PLLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
trametinib and nab-paclitaxel
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02300935
First Posted
November 21, 2014
Last Updated
May 28, 2019
Sponsor
SCRI Development Innovations, LLC
Collaborators
Celgene, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT02300935
Brief Title
Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
Official Title
Phase I Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study concept was terminated.
Study Start Date
December 2015 (Anticipated)
Primary Completion Date
January 20, 2016 (Actual)
Study Completion Date
January 20, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Celgene, GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
trametinib, nab-paclitaxel, Mekinist, Abraxane, unresectable, metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trametinib and nab-paclitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
trametinib
Other Intervention Name(s)
Mekinist
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
Abraxane
Primary Outcome Measure Information:
Title
Number of patients with Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
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.
Time Frame
weekly for the first 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey R. Infante, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Florida Cancer Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
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