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Phase 1 Trial of the Mammalian Target of Rapamycin (mTOR) Inhibitor Everolimus Plus Radiation Therapy (RT) for Salvage Treatment of Biochemical Recurrence in Prostate Cancer Patients Following Prostatectomy

NCT01548807 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-08-22

No results posted yet for this study

Summary

This is a Phase 1 dose escalation study of an investigational agent, everolimus, given in combination with standard radiation therapy, in prostate cancers with a rising PSA following a prostatectomy. A maximum of 33 people will be enrolled on this study at the University of Pennsylvania. The primary objective of this study is to determine the acute and chronic toxicities and maximum tolerated dose of everolimus with concurrent radiation.

Conditions

  • Prostate Cancer Patients With Detectable PSA Following Prostatectomy

Interventions

DRUG

Everolimus (RAD001)

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Naomi Haas, MD · Abramson Cancer Center at Penn Medicine

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2017-01-04
Completion
2017-01-04

Countries

  • United States

Study Locations

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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 NCT01548807 on ClinicalTrials.gov