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Enzyme Inhibitor

ESK981 for Prostate Cancer

Phase 2

Waitlist Available

Led By Elisabeth I. Heath

Research Sponsored by Barbara Ann Karmanos Cancer Institute

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 date that a 25% or greater increase and an absolute increase of 2.0 ng/ml or more from the nadir is documented and confirmed by a second value obtained 3 or more weeks later, assessed up to 1 year

Awards & highlights

Study Summary

This trial looks at the side effects and effectiveness of ESK981 in treating patients with prostate cancer that has spread to other parts of the body. ESK981 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions

Castration-resistant Prostate Cancer
Prostate Cancer
Low Testosterone
Prostate-Specific Antigen

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date that a 25% or greater increase and an absolute increase of 2.0 ng/ml or more from the nadir is documented and confirmed by a second value obtained 3 or more weeks later, assessed up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date that a 25% or greater increase and an absolute increase of 2.0 ng/ml or more from the nadir is documented and confirmed by a second value obtained 3 or more weeks later, assessed up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and date that a 25% or greater increase and an absolute increase of 2.0 ng/ml or more from the nadir is documented and confirmed by a second value obtained 3 or more weeks later, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

PSA Decline of >= 50% (PSA50) From Baseline

Secondary outcome measures

Duration of PSA Response (RD)

PSA Progression Free Survival (PFS)

Time to PSA Response

Other outcome measures

Androgen Receptor (AR) Signaling

Circulating and Disseminated Tumor Cells as Pharmacodynamic Biomarkers

DNA Sequencing of Prostate Tumor

+3 more

Side effects data

From 2023 Phase 2 trial • 13 Patients • NCT03456804

31%

Fatigue

31%

Pain

31%

Back pain

23%

Gastrointestinal disorders - Other, specify

15%

Vascular disorders - Other, specify

15%

Cardiac disorders - Other, specify

15%

Weight loss

15%

Musculoskeletal and connective tissue disorder

15%

Diarrhea

15%

Hypertension

15%

Localized edema

15%

Pain in extremity

15%

Constipation

Vomiting

Urinary frequency

Non-cardiac chest pain

Aspartate aminotransferase increased

Eye disorders - Other, specify

Hyperglycemia

Alanine aminotransferase increased

Muscle weakness lower limb

Nausea

Dehydration

Reproductive system and breast disorders - Othe

Dizziness

General disorders and administration site condi

Generalized muscle weakness

Headache

Hematuria

Hoarseness

Hyponatremia

Hypotension

Insomnia

Lymphedema

Nervous system disorders - Other, specify

Pelvic pain

Sinusitis

Lymphocyte count decreased

Myocardial infarction

Skin infection

Anorexia

Anxiety

Bruising

Chills

100%

80%

60%

40%

20%

Study treatment Arm

Treatment ESK981

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ESK981Experimental Treatment1 Intervention

Patients receive pan-VEGFR/TIE2 (Vascular Endothelial Growth Factor Receptor/angopoeitin receptor2) tyrosine kinase inhibitor CEP-11981 PO QD for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ESK981

2018

Completed Phase 2

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,476 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,113 Patients Enrolled for Prostate Cancer

Barbara Ann Karmanos Cancer InstituteLead Sponsor

163 Previous Clinical Trials

9,243 Total Patients Enrolled

15 Trials studying Prostate Cancer

1,071 Patients Enrolled for Prostate Cancer

Elisabeth I. HeathPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute

Frequently Asked Questions

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

Has ESK981 been granted regulatory authorization by the Food and Drug Administration?

"ESK981's safety was rated a 2 on our scale of 1-3 due to limited efficacy data and the fact that this is an early Phase 2 trial."

Answered by AI

Does this research project currently have the capacity to include more participants?

"This clinical trial is no longer open to new patients, as can be seen on the clinicaltrials.gov website. The project began in March of 2018 and was last updated August 30th 2022. That being said, there are 3650 other medical studies that still need volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer

Elisabeth Heath 2018. "ESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03456804.