Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment

NCT02047253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-12-19

Study results available
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Summary

This study will test how effective the drug, Carfilzomib, reduces progression of prostate cancer in patients who have previously received chemotherapy and androgen inhibitors. Carfilzomib is approved for multiple myeloma but is not approved for prostate cancer. Therefore, it is considered investigational. Other approved methods of treatment for metastatic prostate cancer have demonstrated only modest benefits. Novel and tolerable agents are necessary to make further gains and extend overall survival.

Conditions

Interventions

DRUG

Carfilzomib

Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.

DRUG

Dexamethasone

Administered prior to administration of Study drug

DRUG

Acyclovir

Administered orally twice daily

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY
  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Guru Sonpavde, MD · University of Alabama at Birmingham

  • Mansoor Saleh, MD · Georgia Cancer Specialists

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-06-08
Completion
2017-07-14

Countries

  • United States

Study Locations

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Entities

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 NCT02047253 on ClinicalTrials.gov