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Anti-tumor antibiotic

Peposertib + Chemotherapy for Ovarian Cancer

Phase 1

Recruiting

Led By Rachel N Grisham

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

Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy, if indicated

Patients must have a cardiac ejection fraction >= the institutional lower limit of normal (LLN)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing peposertib + pegylated liposomal doxorubicin hydrochloride to treat ovarian cancer. The combination may work better than doxorubicin hydrochloride alone.

Who is the study for?

This trial is for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Participants must have had at least one prior platinum-based chemotherapy and can be of any age above 18. They should not be pregnant or breastfeeding and must agree to use contraception. People with certain heart conditions, uncontrolled illnesses, or those unable to take oral medication are excluded.Check my eligibility

What is being tested?

The study is testing the combination of a new drug called Peposertib with standard chemotherapy (pegylated liposomal doxorubicin hydrochloride) against ovarian cancer that has returned after treatment. The goal is to find out if this combo is more effective than the standard chemo alone.See study design

What are the potential side effects?

Possible side effects include reactions related to Peposertib such as fatigue, nausea, and potential liver issues; plus typical chemo side effects like hair loss, mouth sores, low blood counts leading to increased infection risk, and heart problems.

Eligibility Criteria

Inclusion Criteria

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

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I have chronic hepatitis B but it's under control with treatment.

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My heart's pumping ability is within the normal range.

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I have recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.

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I am 18 years old or older.

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I can take care of myself but might not be able to do active work.

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I have had platinum-based chemotherapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

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

Secondary outcome measures

Pharmacokinetics (PK) parameters of nedisertib

Other outcome measures

Duration of response

Progression-free survival

Neoplasms

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (peposertib, PLD)Experimental Treatment7 Interventions

Patients receive peposertib PO BID on days 1-21, days 1-28, or days 1-7 (depending on dose level) and pegylated liposomal doxorubicin hydrochloride IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection cycle 1 weeks 1 and 3. Patients also undergo CT scan or MRI during screening and every 8 weeks and after 6 months of study treatment, every 12 weeks. Patients undergo ECHO during screening and every 6 months. Starting in cycle 13, patients undergo ECHO or MUGA scan every 2 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biospecimen Collection

2004

Completed Phase 2

~1700

Echocardiography

2013

Completed Phase 4

~11670

Peposertib

2021

Completed Phase 1

~20

Computed Tomography

2017

Completed Phase 2

~2720

Pegylated Liposomal Doxorubicin Hydrochloride

2001

Completed Phase 3

~4520

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,805 Total Patients Enrolled

5 Trials studying Endometrioid Adenocarcinoma

1,224 Patients Enrolled for Endometrioid Adenocarcinoma

Rachel N GrishamPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Frequently Asked Questions

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

Could you provide a detailed overview of past experiments related to Peposertib?

"Peposertib was initially trialed in 1997 at Spectrum Health Hospital - Butterworth Campus. Since then, 723 completed clinical trials have been conducted with 374 currently active studies being carried out primarily from Madison, Wisconsin."

Answered by AI

What adverse effects have been linked to the prescription of Peposertib?

"Due to its Phase 1 status, our team at Power has assigned Peposertib a score of 1 on the safety scale. This is partly because there are only limited clinical data that support both efficacy and safety."

Answered by AI

How many locations are currently testing this experiment?

"Currently, the recruitment process for this clinical trial is ongoing in the University of Wisconsin Hospital and Clinics (Madison, WI), Memorial Sloan Kettering Westchester (Harrison, NY) , and University of Virginia Cancer Center (Charlottesville VA). Additionally, there are 9 other sites where patients can enroll."

Answered by AI

Is enrollment for this research project still open?

"As per clinicaltrials.gov, this study is currently seeking participants to enroll in the trial. It was first made available on February 24th 2020 and has since been amended as recently as September 2nd 2022."

Answered by AI

Does this experiment possess any historical precedence?

"Established in 1997, when Alfacell launched their first clinical trial of Peposertib involving 300 participants, the drug has seen extensive research and development. Currently, there are 374 ongoing studies for Peposertib conducted across 1944 cities and 67 countries worldwide which has allowed it to receive its Phase 3 approval."

Answered by AI

How many individuals are being chosen to take part in this investigation?

"Confirmed. The clinical trial's listing on the official website reveals that it is indeed actively enrolling patients, with its initial posting being way back in February 2020. This research program requires 49 volunteers to join across 9 sites."

Answered by AI

What is the typical purpose of administering Peposertib?

"To combat rickettsialpox, Peposertib is the most commonly prescribed medication. Additionally, this pharmaceutical can be beneficial for treating prostatitis, conjunctivitis, inclusion body myositis and syphilis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Combining the Peposertib (M3814) Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansion in High Grade Serous Ovarian Cancer and Low Grade Serous Ovarian Cancer

2020. "A Study Combining the Peposertib (M3814) Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansion in High Grade Serous Ovarian Cancer and Low Grade Serous Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04092270.

All > Ovarian Cancer > Recurrent Ovarian Cancer