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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Spirita Oncology, LLC
Study ID
NCT03332589
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • E6201 — DRUG
    E6201 formulated in cyclodextrin for IV administration.
  • E6201 plus dabrafenib — DRUG
    E6201 formulated in cyclodextrin for IV administration. Dabrafenib capsules for oral administration.

Study Details

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.

Key Dates

Start date
Jul 2, 2018
Status verified
Dec 2021
Primary completion
Apr 30, 2021
Completion
Oct 11, 2021

Study Design

Enrollment
4 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Safety Run-in: E6201
    E6201 320 mg/m\^2 administered IV over 2 hours twice weekly on Days 1, 4, 8, 11, 15 and 18, repeated every 28 days (=1 cycle). Dose reductions for toxicity are 240 mg/m\^2 (Dose Level -1) and 160 mg/m\^2 (Dose Level -2) twice weekly.
  • Experimental: Combination Safety Run-in: E6201 Plus Dabrafenib
    Dose Level 1: E6201 320 mg/m\^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -1: E6201 240 mg/m\^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -2: E6201 240 mg/m\^2 twice weekly plus dabrafenib 100 mg BID. Dose Level -3: E6201 160 mg/m\^2 twice weekly plus dabrafenib 100 mg BID Dose Level -4: E6201 160 mg/m\^2 twice weekly plus dabrafenib 75 mg BID. Dose Level -5: E6201 160 mg/m\^2 twice weekly plus dabrafenib 50 mg BID.
  • Experimental: Expansion: E6201 Plus Dabrafenib
    A total of up to N=18 will be treated at the E6201 plus dabrafenib combined MTD.

Primary Outcome Measure

Intracranial Disease Overall Response Rate by RANO-BM [ Time Frame: At the end of Cycle 2 and every 2 cycles through 6 months following last dose of study drug (each cycle is 28 days) up to 1 year. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Arizona Cancer Center· Tucson, AZ

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