MedTrace Logo

Cabazitaxel in mCRPC Patients With AR-V7 Positive Circulating Tumor Cells (CTCs)

NCT03050866 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-08-20

No results posted yet for this study

Summary

After failure on docetaxel, which has been the standard first line therapy for patients with metastatic castration-resistant prostate cancer (mCRPC), several treatment options are currently available.

In retrospective studies, resistance has been described to two of the treatment options, enzalutamide and abiraterone, when a splice variant of the Androgen Receptor (AR-V7) is present on circulating tumor cells (CTCs). The investigators hypothesize that patients with AR-V7 positive CTCs do have a meaningful response to cabazitaxel.

Conditions

Interventions

DRUG

Cabazitaxel

25mg/m2 q3w

OTHER

Antihistamine

As intravenous premedication (dexchlorpheniramine 5 mg, diphenhydramine 25 mg, or equivalent)

OTHER

Corticosteroid

As intravenous premedication (dexamethasone 8 mg or equivalent)

OTHER

H2 antagonist

As intravenous premedication (ranitidine or equivalent)

OTHER

Antiemetic

Antiemetic prophylaxis is recommended and can be given orally or intravenously if necessary

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2022-01-01
Completion
2022-08-19

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03050866 on ClinicalTrials.gov