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New treatment option for Metastatic Colorectal Carcinoma
Official title Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
ClinicalTrials.gov ID: NCT05803382
What this study is testing
What is BET Bromodomain Inhibitor ZEN-3694?
BET Bromodomain Inhibitor ZEN-3694 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic colorectal carcinoma.
Also referred to as BETi ZEN-3694, ZEN 3694.
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 phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET).
- 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
- Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed...
- Dose Escalation additional criteria specifically for colorectal cancer (CRC) patients: Willingness and ability to undergo a pre-treatment biopsy
- Dose Expansion additional criteria: Patients must have histologically confirmed CRC that is metastatic or unresectable and must have progressed on...
- Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
- Patients must have measurable disease
You likely can't join if
- Previous treatment with BET inhibitors
- History of inability to tolerate capecitabine at the projected treatment dose on this trial
- Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors...
- Treatment for HIV, hepatitis B or hepatitis C only if this interferes with the current treatment (e.g. through drug-drug interactions)
- Gastrointestinal pathology or history that adversely impacts the ability to take or absorb oral medication
- Hepatic tumor burden \> 30% or peritoneal carcinomatosis
See the full eligibility criteria
- Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed on standard therapies which would have included fluorouracil (5-FU) or...
- Dose Escalation additional criteria specifically for colorectal cancer (CRC) patients: Willingness and ability to undergo a pre-treatment biopsy
- Dose Expansion additional criteria: Patients must have histologically confirmed CRC that is metastatic or unresectable and must have progressed on standard therapies which would have included 5-FU or capecitabine
- Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
- Patients must have measurable disease
- Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with capecitabine in patients \< 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky \>= 60%)
- Availability of archival tumor tissue at the time of patient enrollment for molecular profiling studies
- Prior to study dosing, previous systemic therapy must have been completed for at least five half-lives or 2 weeks, whichever is shorter
- Absolute neutrophil count \>= 1,000/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin =\< 1.5 institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 x institutional ULN
- Glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients should be New York Heart Association Functional Classification of class 2B or better
- The effects of ZEN003694 (ZEN-3694) and capecitabine on the developing human fetus are unknown. For this reason and because BET inhibitors as well as other therapeutic agents used in this trial are known to be...
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
- Previous treatment with BET inhibitors
- History of inability to tolerate capecitabine at the projected treatment dose on this trial
- Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
- Treatment for HIV, hepatitis B or hepatitis C only if this interferes with the current treatment (e.g. through drug-drug interactions)
- Gastrointestinal pathology or history that adversely impacts the ability to take or absorb oral medication
- Hepatic tumor burden \> 30% or peritoneal carcinomatosis
- Untreated/uncontrolled central nervous system (CNS) disease
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Severe intercurrent illness or comorbidity
- Inability to comply with the protocol and/or not willing or who will not be available for follow-up assessments
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and neuropathy up to and including grade 2
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or other agents used in study
- Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Strong inhibitors of CYP3A4 must be discontinued at least 7 days, and inducers 14 days prior to the first...
- Pregnant women are excluded from this study because ZEN003694 (ZEN-3694) is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in...
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Orange, California, United States
- Gainesville, Florida, United States
- Shiloh, Illinois, United States
- Fairway, Kansas, United States
- Kansas City, Kansas, United States
- Westwood, Kansas, United States
- City of Saint Peters, Missouri, United States
- Creve Coeur, Missouri, United States
- St Louis, Missouri, United States
- New York, New York, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- West Chester, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, 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 Irvine, California, United States; Orange, California, United States; Gainesville, Florida, United States; Shiloh, Illinois, United States; Fairway, Kansas, United States; Kansas City, Kansas, United States and 11 more location(s). 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.