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Tests treatment safety and results for Colorectal Adenomatous Polyp
Official title Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
ClinicalTrials.gov ID: NCT05630794
What this study is testing
What is Dordaviprone Hydrochloride?
Dordaviprone Hydrochloride is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for colorectal adenomatous polyp.
Also referred to as Modeyso.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this phase I trial is to test the safety and cancer preventive effects of different doses of ONC201 in people with familial adenomatous polyposis (FAP) or a history of multiple polyps. People with familial adenomatous polyposis (FAP) or a history of multiple polyps are at higher than average risk of developing colorectal cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be identified as high risk for recurrent colorectal adenomas, as defined by:
- A diagnosis of FAP AND/OR
- Findings of either \> 5 small (less than 1 cm) adenomas OR \>= 3 with at least one \>= 10 mm on most recent colonoscopy performed in the past 5 years
- Be \>= 18 years of age on day of signing informed consent
- Have an Eastern Cooperative Oncology Group (ECOG) performance status =\ = 70%)
You likely can't join if
- Prior history of hereditary nonpolyposis colorectal cancer (HNPCC), also known as Lynch syndrome
- Participants may not be currently receiving any other investigational agents or have received any investigational agents within the past four weeks
- Prior history of invasive colorectal cancer
- Prior invasive active neoplasm that is progressing or requires active treatment within 3 years from registration. Exceptions include basal cell...
- Prior history of exposure to cytotoxic chemotherapy or ONC201
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC201
See the full eligibility criteria
- Be identified as high risk for recurrent colorectal adenomas, as defined by:
- A diagnosis of FAP AND/OR
- Findings of either \> 5 small (less than 1 cm) adenomas OR \>= 3 with at least one \>= 10 mm on most recent colonoscopy performed in the past 5 years
- Be \>= 18 years of age on day of signing informed consent
- Have an Eastern Cooperative Oncology Group (ECOG) performance status =\ = 70%)
- Leukocytes \>= 3,000/microliter
- Absolute neutrophil count \>= 1,000/microliter
- Platelets \>= 100,000/microliter
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum (glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase ([SGPT]) =\< 1.5 x institutional upper limit of normal
- Creatinine =\< 1.5 x institutional upper limit of normal
- Participant is due to undergo a standard of care lower gastrointestinal (GI) colonoscopy for detection and removal of colorectal polyps. On this colonoscopy, participant is required to have:
- Two (2) adenomatous polyps of at least five (5) mm in size
- At least one (1) polyp within reach of a flexible sigmoidoscope (which will be retained in the colon or rectum and marked)
- In addition to polypectomy, six (6) biopsies of normal colonic mucosa \>= 1 cm from a collected polyp will also be collected
- Willing to undergo a second, research intent endoscopic procedure (either sigmoidoscopy or colonoscopy), approximately 12 weeks after initiating ONC201 treatment
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Life expectancy of at least 5-years
- ONC201 is an imipridone agent with the potential for teratogenic or abortifacient effects. For this reason and because imipridones potential teratogenic effects are unknown, men and women of child-bearing potential must...
- Ability to understand and the willingness to sign a written informed consent document
- Prior history of hereditary nonpolyposis colorectal cancer (HNPCC), also known as Lynch syndrome
- Participants may not be currently receiving any other investigational agents or have received any investigational agents within the past four weeks
- Prior history of invasive colorectal cancer
- Prior invasive active neoplasm that is progressing or requires active treatment within 3 years from registration. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has...
- Prior history of exposure to cytotoxic chemotherapy or ONC201
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC201
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Pregnant and women who are nursing are excluded from this study because ONC201 is an imipridone agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for...
- Concomitant use of strong/moderate CYP3A4/5 inducers/inhibitors. These agents must be discontinued at least 72-hours prior to beginning ONC201
- Any of the following cardiac criteria:
- Prolongation of corrected QT (QTc) interval (QTc interval \> 480 milliseconds, preferably using Frederica's QT correction formula), confirmed on electrocardiogram (ECG) tracings performed during screening
- A history of Torsades de pointes, heart failure, or family history of prolonged QT Syndrome
- Concomitant use of drugs that are known to prolong QT and have a known risk of torsade de pointes (TdP) unless they are willing to stop these medications and possibly change to an alternative non-excluded medication to...
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; St Louis, Missouri, United States; Cleveland, Ohio, United States; Columbus, Ohio, United States; Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.