Clinical Trials /

Study of Trametinib and Nab-paclitaxel in Patients With Melanoma

NCT02300935

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Withdrawn

Phase:

Phase 1

Trial Eligibility

Document

Study of <span class="go-doc-concept go-doc-intervention">Trametinib</span> and <span class="go-doc-concept go-doc-intervention">Nab-paclitaxel</span> in Patients With <span class="go-doc-concept go-doc-disease">Melanoma</span>

Title

  • 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
  • Clinical Trial IDs

    NCT ID: NCT02300935

    ORG ID: SCRI MEL 40

    Trial Conditions

    Melanoma

    Trial Interventions

    Drug Synonyms Arms
    trametinib Mekinist trametinib and nab-paclitaxel
    nab-paclitaxel Abraxane trametinib and nab-paclitaxel

    Trial Purpose

    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.

    Trial Arms

    Name Type Description Interventions
    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. trametinib, nab-paclitaxel

    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)

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Trial Keywords

    trametinib

    nab-paclitaxel

    Mekinist

    Abraxane

    unresectable

    metastatic