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MEK Inhibitor

Dose Level 4: Selumetinib for Uveal Melanoma

Phase 1
Waitlist Available
Led By Richard Carvajal, MD
Research Sponsored by Richard D. Carvajal
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 up to 2 years
Awards & highlights

Study Summary

This study is evaluating whether a drug which blocks a protein in cancer cells may help treat uveal melanoma.

Eligible Conditions
  • Uveal Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of intermittent selumetinib
Secondary outcome measures
Number of adverse events (AEs)
Number of serious adverse events (SAEs)
Number of subjects with Dose Limiting Toxicity (DLT)
+3 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose Level 6: SelumetinibExperimental Treatment1 Intervention
Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 225mg.
Group II: Dose Level 5: SelumetinibExperimental Treatment1 Intervention
Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 200mg.
Group III: Dose Level 4: SelumetinibExperimental Treatment1 Intervention
Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 175mg.
Group IV: Dose Level 3: SelumetinibExperimental Treatment1 Intervention
Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 150mg.
Group V: Dose Level 2: SelumetinibExperimental Treatment1 Intervention
Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 125mg.
Group VI: Dose Level 1: SelumetinibExperimental Treatment1 Intervention
Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 100mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib, 200mg
2017
Completed Phase 1
~50
Selumetinib, 100mg
2017
Completed Phase 1
~50
Selumetinib, 225mg
2017
Completed Phase 1
~50
Selumetinib, 125mg
2017
Completed Phase 1
~50
Selumetinib, 150mg
2017
Completed Phase 1
~50
Selumetinib, 175mg
2017
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Richard D. CarvajalLead Sponsor
3 Previous Clinical Trials
731 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,265 Previous Clinical Trials
288,605,240 Total Patients Enrolled
Melanoma Research AllianceOTHER
7 Previous Clinical Trials
484 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Apr 2025