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Anti-tumor antibiotic

Treatment (peposertib, liposomal doxorubicin) for Leiomyosarcoma

Phase 1

Recruiting

Led By Candace L Haddox

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial tests a new chemo combo to treat advanced sarcoma, aiming to shrink/stabilize the tumor cells.

Who is the study for?

Adults with advanced sarcoma that has spread or can't be surgically removed, who have tried at least one treatment but not exceeded a certain dose of anthracycline. They must have acceptable organ function and performance status, no severe cardiac issues, and agree to use contraception. Excludes those with unresolved toxic effects from previous cancer treatments (except hair loss), recent radiation therapy, taking certain drugs affecting liver enzymes or proton-pump inhibitors without stopping them first.Check my eligibility

What is being tested?

The trial is testing the combination of low-dose liposomal doxorubicin (a chemotherapy drug) with peposertib (an anti-cancer drug) in adults with advanced sarcoma. The study aims to find the safest doses, understand side effects better, and see how effective this combo is against cancer that's hard to treat.See study design

What are the potential side effects?

Possible side effects include damage to DNA in cells which may kill cancer cells or block their growth but could also affect healthy cells leading to fatigue, nausea, heart problems among others specific to each drug. Liposomal doxorubicin might cause fewer side effects than regular forms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose limiting toxicity (DLT)

Secondary outcome measures

DNA damage repair activity

Homologous recombination deficiency (HRD) status

Incidence of adverse events

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (peposertib, liposomal doxorubicin)Experimental Treatment6 Interventions

Patients receive peposertib PO BID and pegylated liposomal doxorubicin hydrochloride IV QD during treatment cycles on study. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity or withdrawal of consent. Patients undergo CT or MRI throughout the trial. Patients also undergo blood sample collection and tissue biopsy during screening and on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegylated Liposomal Doxorubicin Hydrochloride

2001

Completed Phase 3

~4520

Peposertib

2021

Completed Phase 1

~20

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,298 Total Patients Enrolled

41 Trials studying Leiomyosarcoma

3,082 Patients Enrolled for Leiomyosarcoma

Candace L HaddoxPrincipal InvestigatorDana-Farber - Harvard 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 apprise me of the potential hazards associated with peposertib, liposomal doxorubicin treatment?

"As this is a Phase 1 trial, there is limited data regarding the safety and efficacy of Treatment (peposertib, liposomal doxorubicin), so it was assigned a score of 1."

Answered by AI

Are participants still being recruited for this research endeavor?

"Affirmative. Clinicaltrials.gov reports that the study, which was first announced on 8th May 2023 is actively recruiting participants and requires a total of 66 patients from just one location. The trial has been recently updated on 20th May 2023 as well."

Answered by AI

How many participants are enrolled in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical investigation is actively seeking patient participation and was first published on May 8th 2023 with a recent edit occurring on the 20th of May that same year. Sixty-six individuals are needed for the trial which will be conducted at one specific site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma

2024. "Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05711615.

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