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Hormone Therapy

Tinengotinib + Standard Treatments for Prostate Cancer

Phase 1 & 2

Recruiting

Led By Wassim Abida, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

ECOG 0 - 2

Progressive disease on enzalutamide or abiraterone acetate documented by PCWG3 criteria for study entry

Must not have

Pre-existing duodenal stent or any gastrointestinal disorder or defect interfering with absorption of study medication

Symptomatic and/or untreated CNS metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if tinengotinib, when taken together with either abiraterone acetate and prednisone or enzalutamide, is a safe treatment with minimal

Who is the study for?

This trial is for individuals with metastatic castration-resistant prostate cancer. Participants should not have had previous treatments that failed and must be healthy enough to take the study medications.

What is being tested?

The trial tests Tinengotinib combined with standard prostate cancer treatments (abiraterone acetate and prednisone or enzalutamide) to see if it's a safe option that only causes mild side effects.

What are the potential side effects?

While specific side effects are not listed, the study aims to determine if Tinengotinib, when used with other prostate cancer drugs, leads to few or mild side effects.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than 50% of my waking hours.

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My cancer has worsened despite taking enzalutamide or abiraterone.

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I have been on hormone therapy for prostate cancer for at least 90 days or have had both testicles surgically removed.

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My prostate cancer diagnosis has been confirmed by a lab test.

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My cancer has spread to my bones or soft tissues, confirmed by scans.

Exclusion Criteria

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

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I don't have any stomach or intestine problems that affect medication absorption.

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I have brain metastases that are causing symptoms or have not been treated.

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I have been treated with drugs that target multiple kinases.

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My cancer is diagnosed as pure small cell carcinoma.

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I have high blood pressure or chest pain due to heart disease that isn't well-controlled.

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I do not have any other cancer that could affect this treatment's safety or results.

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I have not had palliative radiation in the last 2 weeks.

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I have serious heart issues, including recent heart attack or severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate (ORR)

RP2D

Secondary study objectives

Time to Radiographic Response (phase II)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Tinengotinib with abiraterone acetate/prednisoneExperimental Treatment3 Interventions

Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily will be administered unless dose de-escalation is required in Phase 1b. Participants will receive tinengotinib in combination with abiraterone acetate 1000 mg PO QD in combination with prednisone 5 mg PO once or twice daily (QD or BID) or enzalutamide 160 mg PO QD.

Group II: Phase 1b dose of tinengotinib (RP2D) with abiraterone acetate/prednisone or enzalutamideExperimental Treatment3 Interventions

Phase 1b dose of tinengotinib recommended Phase II dose (RP2D) with abiraterone acetate/prednisone or enzalutamide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

abiraterone acetate

2017

Completed Phase 4

~920

0 / 13Eligibility criteria met