Trials / Withdrawn
WithdrawnNCT02300935
Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
Phase I Study of Trametinib and Nab-paclitaxel in Patients With Melanoma
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- SCRI Development Innovations, LLC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | trametinib | |
| DRUG | nab-paclitaxel |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2016-01-20
- Completion
- 2016-01-20
- First posted
- 2014-11-25
- Last updated
- 2019-05-30
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02300935. Inclusion in this directory is not an endorsement.