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Chemotherapy

Enzalutamide + Cabazitaxel for Prostate Cancer

Phase 1 & 2

Waitlist Available

Led By Julie N Graff

Research Sponsored by OHSU Knight 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 up to 5 years

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of cabazitaxel given with enzalutamide for treating prostate cancer that has spread and no longer responds to hormone therapy.

Who is the study for?

This trial is for men with metastatic, hormone-resistant prostate cancer. Participants must have a good performance status (able to carry out daily activities), adequate blood counts and organ function, agree to use double barrier contraception, and be willing to provide a tumor sample if possible. Men who've had certain treatments or have specific health conditions are excluded.Check my eligibility

What is being tested?

The study tests the combination of cabazitaxel (a chemotherapy drug) and enzalutamide (a hormone therapy) on patients with advanced prostate cancer that's spread and doesn't respond to hormonal treatment anymore. The phase I/II trial aims to find the best dose of cabazitaxel when used with enzalutamide.See study design

What are the potential side effects?

Possible side effects include those common to chemotherapy like nausea, hair loss, low blood cell counts leading to increased infection risk or bleeding problems; fatigue; allergic reactions; liver issues; and potential interactions affecting other medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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 Response 1, Defined as >= 90% PSA Decline From Baseline

Percentage of Participants With Dose Limiting ToxicitiesGgraded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (Phase I)

Secondary outcome measures

Incidence of Adverse Events Graded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0

Overall Survival

PSA Response 2, Defined as >= 50% PSA Decline From Baseline

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cabazitaxel, enzalutamide)Experimental Treatment5 Interventions

Patients receive cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2370

Cabazitaxel

2014

Completed Phase 3

~1290

Enzalutamide

2014

Completed Phase 4

~2760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,689 Total Patients Enrolled

27 Trials studying Prostate Cancer

2,433 Patients Enrolled for Prostate Cancer

Oregon Health and Science UniversityOTHER

973 Previous Clinical Trials

6,845,992 Total Patients Enrolled

21 Trials studying Prostate Cancer

7,366 Patients Enrolled for Prostate Cancer

Julie N GraffPrincipal InvestigatorOHSU Knight Cancer Institute

1 Previous Clinical Trials

7 Total Patients Enrolled

Media Library

Cabazitaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02522715 — Phase 1 & 2

Prostate Cancer Research Study Groups: Treatment (cabazitaxel, enzalutamide)

Prostate Cancer Clinical Trial 2023: Cabazitaxel Highlights & Side Effects. Trial Name: NCT02522715 — Phase 1 & 2

Cabazitaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02522715 — Phase 1 & 2

Frequently Asked Questions

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

What objectives is this medical experiment aiming to accomplish?

"The primary objective of this trial, which will be evaluated from the point of baseline to 90% PSA decline or up to 68 weeks, is to assess Dose Limiting ToxicitiesGgraded by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I). Secondary objectives include a 30% Prostate Specific Antigen (PSA) decrease from baseline as recommended by Prostate cancer Working Group 2's PCWG2 recommendations and establishing Pharmacokinetic Parameters such as Max Plasma Concentration (Cmax), Mean Cabazitaxel Half-Life when cabazitaxel is administered alone or"

Answered by AI

What is the aggregate number of subjects involved in this experiment?

"This study is no longer searching for participants, as it was last updated on June 24th 2022. There are still 3657 clinical trials recruiting patients with malignant neoplasms of the prostate and 500 studies involving pharmacological interventions actively enrolling volunteers."

Answered by AI

What earlier investigations of Pharmacological Study have been undertaken?

"Currently, 500 clinical trials are exploring Pharmacological Study. 138 of these studies have progressed to Phase 3 research and the majority are situated in Germantown, Tennessee. However, a total of 21652 locations across the globe house active trials for this pharmacology-based treatment."

Answered by AI

Can new participants register for this research at present?

"According to clinicaltrials.gov, this investigation is no longer open for recruitment and the last edit was made on June 24th 2022 - shortly after its launch in October 13th 2015. Despite this trial's closure, 4157 other medical studies are actively seeking participants at present."

Answered by AI

In what condition(s) is Pharmacological Study typically utilized?

"Pharmacological Study is a common treatment for scalp structure and several other afflictions, such as thyroiditis, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer

Julie Graff 2015. "Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02522715.

All > Recurrent Prostate Cancer