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PAC-1 for Uveal Melanoma

Phase 1 & 2
Waitlist Available
Led By Arkadiusz Dudek, MD, PhD
Research Sponsored by Arkadiusz Z. Dudek, MD
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 a maximum of 15 months
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new cancer drug given with another cancer drug that is already approved.

Eligible Conditions
  • Uveal Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to a maximum of 15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to a maximum of 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Determine Maximum Tolerated Dose (MTD)
Phase 2: Progression Free Survival at 3 Months
Secondary outcome measures
Assess Adverse Events
Overall Survival (OS)
Phase 2: Duration of Response (DoR)
+1 more

Side effects data

From 2019 Phase 1 trial • 28 Patients • NCT03796013
7%
Arthropod bite
4%
Cough
4%
Nasal congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Form A Reference Formulation
Form C Test Formulation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study Treatment ArmExperimental Treatment2 Interventions
Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entrectinib
2014
Completed Phase 2
~360
PAC-1
2015
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Vanquish Oncology, Inc.Industry Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,025 Total Patients Enrolled
HealthPartners Regions Cancer Care and Frauenshuh Cancer Care CentersUNKNOWN
~1 spots leftby Jun 2025
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