Clinical trial for Colorectal Carcinoma
Official title An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
ClinicalTrials.gov ID: NCT06557733
What this study is testing
What is TPST-1495?
an investigational oral medicine being studied for reducing polyp burden in patients with familial adenomatous polyposis (FAP). TPST-1495 is designed to block the prostaglandin E2 (PGE2) EP2 and EP4 receptors, which may affect polyp growth.
Also referred to as Dual EP2/4 Antagonist TPST-1495, PGE2 EP2/EP4 Receptor Antagonist TPST-1495, Prostaglandin E2 Receptor EP2/EP4 Antagonist TPST-1495, TPST 1495, TPST1495.
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
- This study aims to find out if the drug TPST-1495 can lower the number of polyps in the small intestine and colon.
- Who it's for
- The study is looking for people who have Familial Adenomatous Polyposis (FAP), an inherited condition that causes many polyps to grow in the colon.
- What's involved
- Participants will take the study drug TPST-1495 and undergo tests to check the number of polyps in their digestive tract.
- Time commitment
- The source text does not specify the total duration of the study or the required visit schedule.
- Phase 2: a mid-size study of how well it works
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
- Genetic diagnosis with confirmed APC mutation (clinical CLIA [clinical laboratory improvement amendments] certified lab or research testing)
- Obligate carrier
- Clinical diagnosis of classic FAP with ≥ 100 colorectal adenomas status post colectomy or a sub-total colectomy and a family history of FAP
- Clinical diagnosis of FAP, based on personal and family history. Note: This criterion requires documented review and agreement from either the study...
- Previously underwent prophylactic colectomy or sub-total colectomy with IRA (ileo-rectal or ileo-colonic anastomosis) or IPAA at least 12 months...
You likely can't join if
- Use of any other investigational agents ≤ 12 weeks prior to pre-registration
- History of gastric or intestinal ulceration due to NSAID therapy
- Uncontrolled intercurrent illness or recent surgical procedure that in the opinion of the investigative team would limit compliance with study...
- History of invasive malignancy ≤ 3 years prior to pre-registration (exception: adequately treated carcinoma of the cervix, carcinoma in situ, or...
- History of any upper GI surgery that does not permit access to or evaluation of a 10 cm segment of the duodenum that includes the duodenal bulb, i.e.
- Any histologically confirmed high grade dysplasia (HGD) or cancer, gastrointestinal bleeding and requirement for anticoagulation therapy after study...
See the full eligibility criteria
- Genetic diagnosis with confirmed APC mutation (clinical CLIA [clinical laboratory improvement amendments] certified lab or research testing)
- Obligate carrier
- Clinical diagnosis of classic FAP with ≥ 100 colorectal adenomas status post colectomy or a sub-total colectomy and a family history of FAP
- Clinical diagnosis of FAP, based on personal and family history. Note: This criterion requires documented review and agreement from either the study chair or the MW consortium lead investigator
- Previously underwent prophylactic colectomy or sub-total colectomy with IRA (ileo-rectal or ileo-colonic anastomosis) or IPAA at least 12 months before pre-registration evaluation and without ongoing surgical...
- Willing to discontinue taking non-steroidal anti-inflammatory drugs (NSAIDs) 5 days prior to initiation of study treatment and limit frequency of NSAID dosing during study treatment
- Age ≥ 18. Because no dosing or adverse event (AE) data are currently available on the use of TPST-1495 in participants \< 18 years of age, children and adolescents are excluded from this study but will be eligible for...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
- Leukocytes (white blood count [WBC]) ≥ 3,000/uL (≥ 2,500/uL for African American participants)
- Platelet count ≥ 100 x 10\^9/L
- Hemoglobin ≥ 11.5 g/dL
- Total bilirubin ≤ 1.5 x institutional upper limit normal (ULN) (unless patient has Gilbert's)
- Alkaline phosphatase ≤ 1.5 x institutional ULN
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2 x institutional ULN
- Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) ≤ 2 x institutional ULN
- Creatinine ≤ institutional ULN
- Urinary testing results within institutional limits of normal or deemed clinically insignificant
- Individuals on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
- Presence of Spigelman 2 or 3 duodenal polyposis stage assessed by endoscopy
- Not pregnant: The effects of TPST-1495 on the developing human fetus at the recommended therapeutic dose are unknown.
- Not currently breastfeeding
- Ability to understand and the willingness to sign a written informed consent document
- Helicobacter (H.) pylori negative confirmed with gastric biopsy (at time of screening EGD). If positive for H.
- Use of any other investigational agents ≤ 12 weeks prior to pre-registration
- History of gastric or intestinal ulceration due to NSAID therapy
- Uncontrolled intercurrent illness or recent surgical procedure that in the opinion of the investigative team would limit compliance with study requirements
- History of invasive malignancy ≤ 3 years prior to pre-registration (exception: adequately treated carcinoma of the cervix, carcinoma in situ, or basal or squamous cell carcinomas of the skin)
- History of any upper GI surgery that does not permit access to or evaluation of a 10 cm segment of the duodenum that includes the duodenal bulb, i.e. Whipple procedure or similar
- Any histologically confirmed high grade dysplasia (HGD) or cancer, gastrointestinal bleeding and requirement for anticoagulation therapy after study start except for use of low dose aspirin
- Exclusion of patients utilizing strong a moderate inhibitors of CYP2D6 and CYP3A4
- Individuals with evidence of human immunodeficiency virus (HIV) infection will be excluded from the study even if the HIV viral load is undetectable on suppressive therapy.
- Individuals with evidence of chronic hepatitis B virus (HBV) or C virus (HCV) infection will be excluded from the study, even if the HBV/HCV viral load is undetectable on suppressive therapy.
- Individuals with active H. pylori infection that is untreated or refractory to standard antibiotic therapy
- Patients with prior history of peptic ulcers complicated by bleeding, New York Heart Association (NYHA) Classification II-IV, active autoimmune diseases, on anticoagulants at risk of bleeding or abnormal corrected QT...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Madison, Wisconsin, 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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.