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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

Must not have

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 nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694), breastfeeding should be discontinued if the mother is treated with ZEN003694 (ZEN-3694). These potential risks may also apply to other agents used in this study

Known dihydropyrimidine dehydrogenase (DPD) deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have a known DPD deficiency.

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I have a stomach or intestine condition that affects how I absorb pills.

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I am able to follow the study plan and attend all follow-up visits.

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I have been treated with BET inhibitors before.

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More than 30% of my liver is affected by cancer or I have cancer spread in my abdomen lining.

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I am taking blood thinners, but not oral Factor Xa or IIa inhibitors.

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I cannot tolerate the capecitabine dose planned for this trial.

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I have a brain condition that hasn't been treated or controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Maximum tolerated dose (MTD)

Recommended phase 2 dose (RP2D)

Secondary study objectives

Anti-tumor activity of ZEN003694 (ZEN-3694) in combination with capecitabine

Molecular subpopulations particularly sensitized to BETi and capecitabine

Objective response rate (ORR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Computed Tomography

2017

Completed Phase 2

~2740