Study of PAC-1 and Entrectinib for Patients With Metastatic 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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to a maximum of 15 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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