Clinical Trials Using BMI1 Inhibitor PTC596
Clinical trials are research studies that involve people. The clinical trials on this list are studying BMI1 Inhibitor PTC596. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
A Study of PTC596 in Combination With Dacarbazine in Participants With Advanced Leiomyosarcoma (LMS)
The primary objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of PTC596 in combination with dacarbazine for the treatment of advanced LMS and determine the overall safety profile of PTC596 in combination with dacarbazine. This study will employ the time-to-event continual reassessment method (TITE-CRM) for dose finding. Treatment will be initiated at dose level 2 (DL2) (Dacarbazine 1000 milligrams per square meter [mg / m^2] intravenously (IV) every 21 days in combination with PTC596 200 milligrams [mg] orally twice weekly) for the first participant. This dose level represents the investigator's best assessment of the MTD based on available toxicity data for both agents. For subsequent participants, the dose level at which treatment is initiated will be selected based on the TITE-CRM using the most up to date dose-limiting toxicity (DLT) information from all participants previously treated. Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason (study intervention discontinuation and participant discontinuation / withdrawal).
Location: 4 locations
PTC596 in Treating Patients with Newly Diagnosed Unresectable Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Receiving Chemotherapy
This phase Ib trial studies the side effects and best dose of PTC596 in treating patients with newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer that cannot be removed by surgery who are receiving standard of care chemotherapy. PTC596 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Location: University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma
A Phase 1b Study of PTC596 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma
In this research study the investigators want to learn more about the safety of the study drug, PTC596 has when taken during radiation. The investigators also want to learn about the effects, if any, these drugs have on children and young adults with brain tumors. The investigators are asking people to be in this research study who have been diagnosed with a high grade glioma (HGG) including diffuse intrinsic pontine glioma (DIPG) to be in the research, because they have scheduled to have radiation to treat their cancer. The study is divided into two parts. The goal of the first part is to find the dose of PTC596 that can be given with radiation without causing serious side effects. The purpose of this surgical study is to test the amount of a study drug that may be found in the tumor and blood when given prior to and during a planned surgery for removal of the recurrent tumor. The goals of the first part: - Find the highest safe dose of PTC596 that can be given together with radiation therapy without causing severe side effects; - Learn what kind of side effects can be caused by PTC596 with radiation therapy; - Learn more about the pharmacology of PTC596; - Learn more about the biological effects of PTC596 on the cells in their body including any changes to the tumor DNA; - Determine whether PTC596 with radiation therapy is a beneficial treatment for their tumor; - Determine if there are any changes to participants quality of life when taking PTC596. The goals of the surgical part are: - Learn if PTC596 is able to reach the tumor in the brain; - Learn what kind of side effects can be caused by PTC596 with radiation therapy; - Learn more about the pharmacology of PTC596; - Learn more about the biological effects of PTC596 on the cells in their body including any changes to the tumor DNA; - Determine whether PTC596 with radiation therapy is a beneficial treatment for their tumor; - Determine if there are any changes to their quality of life when taking PTC596. Funding Source - FDA OOPD
Location: Children's Hospital Colorado, Aurora, Colorado