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A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

Clinical Trial Details

This is a clinical trial for adult men diagnosed with metastatic castration-resistant prostate cancer (mCRPC) in which standard therapy has failed or who failed to achieve a complete or partial response to treatment.

The purpose of this research study is to determine the safe and tolerable dose of the investigational drug PT-112, in participants with mCRPC who have previously received at least three prior therapies. Other goals of this research study are to assess whether PT-112 can slow the progression of this disease. 

   
PT-112 is an experimental treatment which means it has not yet been approved by the U.S. Food and Drug Administration (FDA).

  
PT-112 is administered through a vein as an infusion for one hour. Before each administration, participants will receive a medication to prevent nausea. Administration of the prophylactic medication and PT-112 will require 90 minutes on treatment days. PT-112 will be given on days 1 and 15 of each 28-day study cycle.
   
Participants will remain on the study until they are deriving benefit from it. After the participants stop taking the drug, they will be contacted every 12 weeks to check how they are doing. 

Key Eligibility: 
  1. Open to men above the age of 18 who have been diagnosed with metastatic castrate-resistant prostate cancer (mCRPC) for which standard therapy has failed or which failed to achieve a complete or partial response to treatment.
  2. Participants must not have received any cytotoxic chemotherapy within 21 days before initiation of study drug.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Brooklyn

Contact(s)

Mary Palmer
929-470-9475

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2006022182

ClinicalTrials.gov:

NCT02266745

Sponsor:

PT-112-101

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease