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Trial · Interventional

TerminatedPhase 1/2Results postedRegistry data

Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

NCTNCT00924807 (opens ClinicalTrials.gov in a new tab)Other idIRB# 004-08Other idSR06-959
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 1/2
Enrollment
4 participants (actual)
Sponsor
Beth Israel Medical Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Sept 2008
Primary completion
Dec 2013
Completion
Dec 2013
First posted
19 Jun 2009 (estimated)
Last update posted
11 Dec 2018
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011201220132014
  1. Ph 1/2

    Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

    NCT00924807

    Sept 2008 to Dec 2013

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.

Interventions

  • Leuprolide acetate, Bicalutamide, SorafenibDrug

Arms1

  • Experimental

    Androgen Depr, Radiotherapy, Sorafenib

    Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.

    Time frame · Day 29 and every 2 weeks

    Registry description

    Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Secondary outcomes(1)

  1. Biochemical Disease-free Survival

    Time frame · after 9 months

    Registry description

    Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Day 29 and every 2 weeks

Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.

GroupValue
Androgen Depr, Radiotherapy, Sorafenibnot posted
Secondary and other outcome results(1)
Secondary outcome· after 9 months

Biochemical Disease-free Survival

GroupValue
Androgen Depr, Radiotherapy, Sorafenibnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Androgen Depr, Radiotherapy, SorafenibEveryone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy. Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg–0 / 44 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. Intermediate risk disease comprises T2b/c tumors, Gleason 7 histology, or PSA 10-20. High risk tumors comprise T3-4, Gleason 8 or higher histology, or PSA greater than 20. * Age \> 18 years. * Life expectancy of greater than 5 years. * Patients must have normal organ and marrow function. * No pelvic lymph node metastases based on pelvic CT scan or MRI. * No bone metastasis. A whole body bone scan is required to rule out metastatic disease. Exclusion Criteria: * Any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma. * Patients may not be receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study. * Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C. * Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.

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