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PARP Inhibitor

Niraparib for Ovarian Cancer

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years (study population)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Duration of Response

Objective response rate (ORR) by RECIST 1.1

Overall survival (OS)

+3 more

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

~1540

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Haider MahdiLead Sponsor

5 Previous Clinical Trials

167 Total Patients Enrolled

3 Trials studying Ovarian Cancer

97 Patients Enrolled for Ovarian Cancer

Zenith EpigeneticsIndustry Sponsor

9 Previous Clinical Trials

586 Total Patients Enrolled

1 Trials studying Ovarian Cancer

33 Patients Enrolled for Ovarian Cancer

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,070,790 Total Patients Enrolled

23 Trials studying Ovarian Cancer

16,424 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How detrimental can the use of Niraparib be to an individual's health?

"Due to the initial nature of its clinical trials, niraparib has been rated a 1 on our safety scale. This indicates that there is minimal evidence for both efficacy and potential risks associated with this drug."

Answered by AI

Does this research initiative have room for new participants?

"The information posted on clinicaltrials.gov confirms that this particular medical trial is not open to new enrolments at the present moment. Initially hosted on December 31st 2023, it was last updated 6 days ago. Nevertheless, there are 1382 other research studies actively seeking participants across the world right now."

Answered by AI

What are the main goals of this scientific inquiry?

"According to the documentation provided by Zenith Epigenetics, this clinical trial will measure Treatment-related Adverse Events (AE) and Serious Adverse Events (SAE), Duration of Response, Progression-Free Survival (PFS), and Overall Survival (OS). All outcomes are set within a twelve month evaluation period. Complete Response requires all target lesions to disappear with any pathological lymph nodes reduced in their short axis lower than 10 mm; Partial Response necessitates a 30% decrease from baseline sum diameters; Progressive Disease is signified by an increase in the sum diameter of target lesions greater than 20%, as well as 5mm absolute growth"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors

Haider Mahdi 2024. "ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161493.

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