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Antimetabolite
ZEN003694 + Chemotherapy for Colorectal Cancer
Phase 1
Recruiting
Led By Dennis Hsu
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky >= 60%)
Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial tests a new drug combined with chemotherapy to treat metastatic/unresectable cancer, with an aim to shrink tumors better.
Who is the study for?
This trial is for adults with metastatic or unresectable cancers that have worsened after standard treatment, including fluorouracil or capecitabine. Participants must be HIV-positive on effective therapy, if applicable, and cannot have used BET inhibitors before. They should not have severe illnesses that could interfere with the study and must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing ZEN003694 combined with usual chemotherapy (capecitabine) to see if it's safe and what the best dose might be for treating advanced solid tumors. ZEN003694 targets proteins involved in tumor growth, while capecitabine interferes with cancer cell DNA.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression such as infections, liver issues due to drug interactions, digestive problems affecting medication absorption, blood disorders like low platelet counts or neutrophils, and possibly fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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I am willing and able to have biopsies before and during treatment.
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My heart condition allows me to perform moderate activities without discomfort.
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I am 18 years old or older.
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My kidney function, measured by GFR, is normal or only mildly reduced.
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My colorectal cancer is advanced, cannot be surgically removed, and has not responded to standard treatments including 5-FU or capecitabine.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My cancer is advanced, cannot be surgically removed, and has not responded to treatments including 5-FU or capecitabine.
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My hepatitis B virus load is undetectable with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose (MTD)
Recommended phase 2 dose (RP2D)
Secondary outcome measures
Anti-tumor activity of ZEN003694 (ZEN-3694) in combination with capecitabine
Molecular subpopulations particularly sensitized to BETi and capecitabine
Objective response rate (ORR)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ZEN003694, capecitabine)Experimental Treatment7 Interventions
Patients receive ZEN003694 PO QD and capecitabine PO BID 2 weeks on, 1 week off during each treatment cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI, PET/CT, and collection of blood samples throughout the trial. Patients may also undergo biopsies during screening and while on the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biospecimen Collection
2004
Completed Phase 2
~1700
Capecitabine
2013
Completed Phase 3
~3420
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,411 Total Patients Enrolled
Dennis HsuPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I am willing and able to have biopsies before and during treatment.I finished my last cancer treatment at least 2 weeks ago or 5 half-lives ago, whichever is shorter.I have a stomach or intestine condition that affects how I absorb pills.I have a known DPD deficiency.I have recovered from side effects of previous cancer treatments, except for hair loss or mild nerve pain.My brain scans show no worsening after treatment for brain metastases.I can understand and am willing to sign the consent form, or I have someone who can legally do it for me.I agree to use effective birth control during and 6 months after the study.My heart condition allows me to perform moderate activities without discomfort.My HIV, hepatitis B, or C treatment doesn't conflict with my current cancer treatment.I am 18 years old or older.I have another cancer type, but it won't affect this trial's treatment.My kidney function, measured by GFR, is normal or only mildly reduced.I am able to follow the study plan and attend all follow-up visits.I am not pregnant or breastfeeding.My colorectal cancer is advanced, cannot be surgically removed, and has not responded to standard treatments including 5-FU or capecitabine.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I have been treated with BET inhibitors before.I do not have any severe illnesses besides my current condition.More than 30% of my liver is affected by cancer or I have cancer spread in my abdomen lining.I am taking blood thinners, but not oral Factor Xa or IIa inhibitors.I cannot tolerate the capecitabine dose planned for this trial.I am not taking any strong medication that affects liver enzymes.I am HIV positive, on treatment, and my viral load is undetectable.My cancer is advanced, cannot be surgically removed, and has not responded to treatments including 5-FU or capecitabine.I have a brain condition that hasn't been treated or controlled.You are not allowed to take any other experimental drugs during the study.You have had allergic reactions to drugs that are similar to ZEN003694 (ZEN-3694) or other drugs used in this study.I am willing and able to have a biopsy before treatment for my colorectal cancer.My hepatitis B virus load is undetectable with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ZEN003694, capecitabine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for more participants in this research project?
"Affirmative. From the information present on clinicaltrials.gov, this medical investigation is currently enrolling participants. The trial was initially made public on April 5th 2024 and most recently updated on July 21st 2023. This research requires 30 subjects from one site to take part in it."
Answered by AI
Is the FDA sanctioning the utilization of ZEN003694, capecitabine?
"As this is a phase 1 investigational trial, with limited data regarding safety and efficacy, the team at Power rate the treatment (ZEN003694, capecitabine) as having an overall safety score of one."
Answered by AI
What core aims is this medical experiment seeking to achieve?
"The primary outcome of this investigation, assessed within 30 days after the last dose administered, is to determine maximum tolerated dosage. Secondary aims include measuring overall response rate, pharmacokinetics and pharmacodynamics in combination with capecitabine; specifically ribonucleic acid sequencing of death receptor 5 (DR5) and apoptosis by Pharmacodynamic Assay Development and Implementation Section lab will be evaluated using paired non-parametric tests at a significance level (alpha) of 0.05."
Answered by AI
How many participants are being included in this clinical trial?
"Affirmative. Information accessible on clinicaltrials.gov reveals that this medical experiment, first posted to the website on April 5th 2024, is actively enrolling participants. The trial requires 30 patients from one specific location."
Answered by AI
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