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Cohorts of Docetaxel or Cabazitaxel in Combination With the Potent CYP3A4 Inhibitor, Clarithromycin

NCT03043989 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-02-17

No results posted yet for this study

Summary

This clinical trial is being conducted to recommend a safe and tolerable phase 2 dose of docetaxel or cabazitaxel when combined with clarithromycin in men who have developed castrate-resistant prostate cancer.

In the castrate-resistant setting, resistance to taxane therapy inevitably develops. Men who develop resistance to taxanes have a very poor prognosis, and few treatment options.

It is believed that CYP enzymes contribute to docetaxel and cabazitaxel resistance in metastatic prostate cancer, and this resistance can be mitigated through pharmacologic CYP inhibition. In this study a potent CYP3A inhibitor, clarithromycin, will be co-administered concurrently with either docetaxel or cabazitaxel, whose systemic metabolism is dependent of CYP3A4, with the intent to overcome resistance to taxanes.

Conditions

Interventions

DRUG

Docetaxel

6 infusions of Docetaxel with 18 doses clarithromycin

DRUG

Cabazitaxel

6 infusions of Cabazitaxel with 18 doses clarithromycin

DRUG

Clarithromycin

18 doses of clarithromycin with either Docetaxel or Cabazitaxel

Sponsors & Collaborators

  • Maryland Technology Development Corporation

    collaborator UNKNOWN

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Michael A Carducci, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-21
Primary Completion
2019-07-26
Completion
2019-07-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03043989 on ClinicalTrials.gov