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E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS)

NCT03332589 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-05-20

Study results available
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Summary

This is a Phase 1 study of E6201 plus dabrafenib for the treatment of CNS metastases in BRAF V600-mutated metastatic melanoma. A total of up to N=28-34 subjects with melanoma metastasized to the CNS will be included.

Conditions

Interventions

DRUG

E6201

E6201 formulated in cyclodextrin for IV administration.

DRUG

E6201 plus dabrafenib

E6201 formulated in cyclodextrin for IV administration. Dabrafenib capsules for oral administration.

Sponsors & Collaborators

  • University of Arizona

    collaborator OTHER

  • Spirita Oncology, LLC

    lead INDUSTRY

Principal Investigators

  • Hani M Babiker, MD · University of Arizona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2021-04-30
Completion
2021-10-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03332589 on ClinicalTrials.gov