Purpose of this Study
We are doing this study to learn if a new study drug called PT-112 is a safe and effective treatment for metastatic, castrate-resistant prostate cancer. This study is one of the first times PT-112 is being tested in humans. The study drug has been shown to induce cell death in tumor cells, and shrink tumors in animal studies. This study will also teach us how long the study drug stays in your body after you receive it.
Who Can Participate?
Eligibility
Adults who:
- Are diagnosed with mCRPC
- Are currently taking an androgen deprivation therapy OR have had a bilateral orchiectomy
- Have previously received at least 3 prior therapies for mCRPC, including at least one next-generation anti-androgen therapy and at least one taxane-containing therapy
For more information about who can join this study, please contact the study team at catrin.davies@duke.edu.
- Are diagnosed with mCRPC
- Are currently taking an androgen deprivation therapy OR have had a bilateral orchiectomy
- Have previously received at least 3 prior therapies for mCRPC, including at least one next-generation anti-androgen therapy and at least one taxane-containing therapy
For more information about who can join this study, please contact the study team at catrin.davies@duke.edu.
What is Involved?
If you choose to join this study, you will:
- Receive the study drug through a vein in your arm (IV) once every 2 weeks
- Have blood draws
- Have imaging tests (CT, MRI, and/or bone scan)
- Receive the study drug through a vein in your arm (IV) once every 2 weeks
- Have blood draws
- Have imaging tests (CT, MRI, and/or bone scan)
Study Details
Full Title
A Phase 1, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Patients with Advanced Solid Tumors and Subsequent Expansion Cohorts: Cohort D A Phase 1/2, Open-Label Expansion Cohort to Evaluate the Safety and Preliminary Evidence of Efficacy of 360 mg/m2 or 250 mg/m2 PT-112 Given Bi-weekly in Late-line Treatment of Patients with mCRPC
Principal Investigator
Christopher
Hoimes
Protocol Number
PRO00110069
NCT ID
NCT02266745
Phase
I/II
Enrollment Status
OPEN TO ACCRUAL