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Targeted Therapy

Monotherapy Safety Run-in: E6201 for Brain Tumor

Phase 1
Waitlist Available
Led By Hani M Babiker, MD
Research Sponsored by Spirita Oncology, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Summary

This trial is testing a new treatment for melanoma that has spread to the brain. Up to 34 people will be enrolled.

Eligible Conditions
  • Brain Tumor
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intracranial Disease Overall Response Rate by RANO-BM
Intracranial Disease Overall Response Rate by RECIST 1.1
Secondary study objectives
Intracranial Disease Duration of Response
Overall Survival
Progression-Free Survival
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Monotherapy Safety Run-in: E6201Experimental Treatment1 Intervention
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.
Group II: Expansion: E6201 Plus DabrafenibExperimental Treatment1 Intervention
A total of up to N=18 will be treated at the E6201 plus dabrafenib combined MTD.
Group III: Combination Safety Run-in: E6201 Plus DabrafenibExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E6201
2008
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

University of ArizonaOTHER
525 Previous Clinical Trials
155,244 Total Patients Enrolled
Spirita Oncology, LLCLead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled
Hani M Babiker, MDPrincipal InvestigatorUniversity of Arizona
~1 spots leftby Sep 2025
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