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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
1,539 Previous Clinical Trials
567,683 Total Patients Enrolled
HealthPartners Regions Cancer Care and Frauenshuh Cancer Care CentersUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open window for enrollment in this experiment?

"According to the info on clinicaltrials.gov, this particular trial has ceased its recruiting efforts. The posting was put up in January of 2021 and last updated in November of 2022. Despite these findings, there are still 774 other studies actively seeking participants right now."

Answered by AI

What is the volume of participants being considered for this clinical experiment?

"This medical investigation is no longer recruiting. It was initially posted on the 11th of January 2021 and last updated on November 15th 2022. If you are still looking for trials, there are currently 756 studies accepting patients with uveal neoplasms and 18 clinical investigations actively enrolling participants in relation to PAC-1."

Answered by AI

Has PAC-1 been explored previously in any other research pursuits?

"Currently, 18 clinical trials are being conducted to examine the efficacy of PAC-1. Of those studies, 3 are currently in Phase 3 and there is a total of 1592 sites where these experiments take place; Portland, Oregon houses the majority of them."

Answered by AI

What benefits are expected to be yielded by this research endeavor?

"Genentech, Inc., the sponsor of this trial, has indicated that Phase 1b: Determine Maximum Tolerated Dose (MTD) will be measured as its primary outcome over a 3-month period. Secondary outcomes to be evaluated include Duration of Response (DoR), Overall Survival (OS), and Overall Response Rate (ORR). DoR is established by documenting complete or partial response until disease progression occurs; OS is calculated from treatment commencement with PAC-1 in conjunction with entrectinib to death due to any cause; ORR is the sum of subjects displaying either full or partial responses under RECIST 1."

Answered by AI

Is this assessment the first of its kind?

"At present, 18 PAC-1 trials have been initiated in 482 cities and 54 countries. The initial examination of this drug was conducted under the auspices of Hoffmann-La Roche in 2015 with a sample size of 700 people. It completed Phase 2 clinical approval and since then there has been 8 additional studies done on it."

Answered by AI

What are the typical applications of PAC-1 treatment?

"The therapeutic measure is commonly managed with PAC-1, which can also work to abate the symptoms of ailments such as tumors and malignant neoplasms."

Answered by AI
~1 spots leftby Apr 2025