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PARP Inhibitor

ZEN003694 + Niraparib for Solid Tumors

Phase 1

Waitlist Available

Led By Haider S Mahdi, MD

Research Sponsored by Haider Mahdi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have had no more than 5 prior cancer therapy treatment regimens, of which a maximum of 4 were cytotoxic chemotherapy or DNA-damaging agents like PARPi-containing regimens

Known BRCA1/2 status or willing to be tested

Must not have

Patients with not adequately controlled hypertension despite adequate medical treatment

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years (study population)

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate a new cancer treatment with ZEN003694 & niraparib to see if it can help patients with metastatic or recurrent solid cancer. Dose levels will be adjusted until it is safe and effective.

Who is the study for?

This trial is for adults with certain types of advanced solid tumors that have come back or spread and who've already tried standard treatments. They should be relatively healthy otherwise, able to take pills, not pregnant or breastfeeding, and not planning to get pregnant. People can't join if they're taking certain other drugs, have serious heart problems, uncontrolled high blood pressure, active infections like HIV or hepatitis B/C, brain metastases that aren't stable for at least 6 months, or any other major health issues.

What is being tested?

The study is testing the combination of two oral medications: Niraparib and ZEN003694. Patients will take these daily in cycles lasting 28 days to see what dose works best without causing too many side effects. The treatment continues until the cancer grows again or the side effects become too much.

What are the potential side effects?

Possible side effects from Niraparib include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems; ZEN003694 could cause similar issues but may also affect how your liver functions. Both drugs might interact with others you're taking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had 5 or fewer cancer treatments, with no more than 4 being strong chemotherapy.

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I know my BRCA1/2 status or am willing to get tested.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has returned or spread and doesn't respond to standard treatments.

Exclusion Criteria

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

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My high blood pressure is not well-controlled despite taking medication.

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

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I have had PRES in the past.

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I do not have any non-healing wounds, ulcers, or bone fractures.

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I do not have serious heart problems like uncontrolled irregular heartbeats or severe heart failure.

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I have not had a heart attack or unstable chest pain in the last 6 months.

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I have been diagnosed with myelodysplastic syndrome.

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I do not have any major health issues that could affect my safety or participation in the study.

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I don't have any active cancer needing treatment, except for certain skin cancers or cervical cancer in situ.

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I do not have active hepatitis B or untreated hepatitis C, and I am not HIV positive.

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More than a quarter of my bone marrow has been exposed to radiation.

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I have been treated with an experimental BET inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years (study population)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years (study population)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years (study population) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)

Treatment-related Adverse Events (AE) and Serious Adverse Events (SAE)

Secondary study objectives

Duration of Response

Objective response rate (ORR) by RECIST 1.1

Overall survival (OS)

+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: NiraparibExperimental Treatment2 Interventions

ZEN003694: Oral capsules - Starting dose 36 mg Dose escalated to 48 mg, following the mTPI-2/Keyboard design administered orally once daily in 28-day cycles Niraparib: Oral tablets - Starting dose 100 mg Dose escalated to 200 mg, following the mTPI-2/Keyboard design administered once daily at the same time as ZEN003694

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ZEN003694

2016

Completed Phase 2

~120

Niraparib

2018

Completed Phase 4

~2400