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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
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 belowSelect...
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:Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
RP2D
Secondary outcome measures
Time to Radiographic Response (phase II)
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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,541 Total Patients Enrolled
133 Trials studying Prostate Cancer
51,578 Patients Enrolled for Prostate Cancer
TransThera SciencesUNKNOWN
Wassim Abida, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
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