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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

Summary

This trial tests PAC-1 and Entrectinib, which are oral medications. PAC-1 is taken over a few weeks, and Entrectinib is taken daily. The trial targets patients with diseases like cancer. PAC-1 kills cancer cells, and Entrectinib stops them from growing. Paclitaxel (PAC) is one of the major anti-cancer drugs, effective in different tumors.

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

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

Side effects data

From 2021 Phase 1 trial • 38 Patients • NCT04226833
8%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Entrectinib Moderate
Entrectinib Mild
Entrectinib Severe
Entrectinib - Normal

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
PAC-1
2015
Completed Phase 1
~50
Entrectinib
2014
Completed Phase 2
~360

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
1,550 Previous Clinical Trials
568,358 Total Patients Enrolled
HealthPartners Regions Cancer Care and Frauenshuh Cancer Care CentersUNKNOWN
~1 spots leftby Sep 2025
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