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ONCT-534 for Prostate Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Oncternal Therapeutics, Inc

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 108 weeks

Awards & highlights

Study Summary

This trial tests a new treatment for prostate cancer to find safe doses and if it has anti-tumor activity. It involves daily doses of the investigational drug ONCT-534.

Who is the study for?

This trial is for men over 18 with metastatic castration-resistant prostate cancer that has progressed after treatment. They must have good kidney, liver, and lung function, a specific type of prostate cancer without certain features, and at least one measurable lesion or evaluable bone disease. Participants need to maintain hormone therapy or be surgically sterile and use contraception.Check my eligibility

What is being tested?

ONCT-534 is being tested in this study to find the safest doses (Phase 1) and check if it can shrink tumors (Phase 2). Patients will take ONCT-534 daily by mouth. The study gradually increases doses to determine safety before assessing its effectiveness against tumors.See study design

What are the potential side effects?

While the side effects of ONCT-534 are not detailed here as it's a first-in-human trial, common side effects from similar treatments may include nausea, fatigue, diarrhea, skin reactions, hormonal changes affecting mood or energy levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 108 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~108 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 108 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assess safety and tolerability of ONCT-534

Complete Response Rate

Determination of the MTD of ONCT-534

+7 more

Secondary outcome measures

Assess Area Under the Curve (AUC) of ONCT-534

Assess Maximum Plasma Concentration (Cmax) of ONCT-534

Correlate anti-tumor activity of ONCT-534 with AR phenotype

Trial Design

7Treatment groups

Experimental Treatment

Group I: Dose Level 5: 600mgExperimental Treatment1 Intervention

600mg of single agent ONCT-534 to be administered daily in oral tablets

Group II: Dose Level 4: 300mgExperimental Treatment1 Intervention

300mg of single agent ONCT-534 to be administered daily in oral tablets

Group III: Dose Level 3: 160mgExperimental Treatment1 Intervention

160mg of single agent ONCT-534 to be administered daily in oral tablets

Group IV: Dose Level 2: 80mgExperimental Treatment1 Intervention

80mg of single agent ONCT-534 to be administered daily in oral tablets

Group V: Dose Level 1: 40mgExperimental Treatment1 Intervention

40mg of single agent ONCT-534 to be administered daily in oral tablets

Group VI: Dose Level #2Experimental Treatment1 Intervention

Recommended Phase 2 dose level #2 of single agent ONCT-534 to be administered daily in oral tablets

Group VII: Dose Level #1Experimental Treatment1 Intervention

Recommended Phase 2 dose level #1 of single agent ONCT-534 to be administered daily in oral tablets

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Oncternal Therapeutics, IncLead Sponsor

6 Previous Clinical Trials

271 Total Patients Enrolled

Salim Yazji, MDStudy DirectorOncternal Therapeutics

Frequently Asked Questions

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

How many individuals are participating in this clinical research?

"This trial requires 59 individuals that meet the requirements to take part. Potential participants can join from NEXT Oncology, located in Austin Texas, or Next Virginia based out of Fairfax,Virginia."

Answered by AI

Are there any availabilities for individuals to join this experiment?

"Affirmative, the data hosted on clinicaltrials.gov confirms that this medical study - first revealed on September 20th 2023- is currently recruiting candidates. The trial seeks 59 participants from 3 different healthcare facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.

2023. "A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05917470.

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