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Kinase Inhibitor

BTX-A51 for Liposarcoma

Phase 1

Recruiting

Research Sponsored by Michael Wagner

Eligibility Criteria Checklist

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

Must have

Adequate organ and marrow function as defined by specific metrics within 7 days of study enrollment

ECOG performance status ≤2

Must not have

Active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)

Active central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up orr expected to be observed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether the standard dose of BTX-A51 is safe and well-tolerated in individuals with liposarcoma. Summary: This trial is testing the safety and tolerability

Who is the study for?

Adults with specific subtypes of liposarcoma that have spread or returned, and who haven't had cancer treatment in the last 14 days. They must be able to swallow pills, not be pregnant, agree to use two contraception methods during and after the study, have stable vital organ functions, and an ECOG performance status ≤2.

What is being tested?

The trial is testing BTX-A51 (a kinase inhibitor) for safety and tolerability in patients with liposarcoma. Participants will receive a recommended dose to see how well they handle it and if there are any beneficial effects on their condition.

What are the potential side effects?

Specific side effects of BTX-A51 aren't listed here but typically kinase inhibitors can cause fatigue, nausea, skin rash, high blood pressure among others. The severity varies from person to person.

Eligibility Criteria

Inclusion Criteria

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

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My organ and bone marrow functions meet the required levels for the study.

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

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I am 18 years old or older.

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My cancer is a specific type of liposarcoma that has spread or come back.

Exclusion Criteria

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

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I do not have an active hepatitis B or C infection.

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I have active brain issues related to my cancer or had a severe reaction to treatment affecting my brain.

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I have not had a heart attack in the last year.

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I haven't had major surgery or an open biopsy in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ orr expected to be observed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~orr expected to be observed up to 3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with adverse events, with laboratory abnormalities, with dose modifications, delays, interruptions, or premature discontinuation of BTX-A51 due to an adverse event

Secondary study objectives

1-year Overall Survival (OS)

1-year Progression-Free Survival (PFS) Rate

Overall Response Rate (ORR)

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: BTX-A51Experimental Treatment1 Intervention

Participants will be enrolled and will complete study procedures as follows: * Baseline visit with tumor biopsy. * Tumor biopsy at the end of Cycle 1. * Radiologic imaging every 2 cycles. * Cycle 1 through End of Treatment: --Day 1 of 28 day cycle: Predetermined dose of BTX-A51 3x weekly. * End of Treatment visit with radiologic imaging. * Follow-up: every 3 months for 1 year.

0 / 8Eligibility criteria met