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Anti-tumor antibiotic

Low-Dose Chemotherapy + Anti-Cancer Drug for Sarcoma

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

No Placebo-Only Group

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.

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.

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

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

Primary study objectives

Dose limiting toxicity (DLT)

Secondary study objectives

DNA damage repair activity

Homologous recombination deficiency (HRD) status

Incidence of adverse events

+2 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 (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

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790