NCT00619996

Brief Summary

The purpose of this study is to use Sorafenib plus Docetaxel to evaluate pharmacodynamics (PD) in Patients with prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 26, 2009

Status Verified

February 1, 2009

Enrollment Period

10 months

First QC Date

February 11, 2008

Last Update Submit

February 25, 2009

Conditions

Prostate Cancer

Keywords

Prostate CancerSorafenibNexavarDocetaxelPisaRicci

Outcome Measures

Primary Outcomes (1)

  • N° of no progressive disease

    1 year

Secondary Outcomes (1)

  • ORR,Duration of responses,TTP,OS,PSA doubling time, PK-PD,of Sorafenib plus docetaxel,Baseline pERK concentration, phospho VEGF-R2 concentration, plasma proteomics and gene expression profiling on blood cells and tumor biopsy.

    1 year

Study Arms (1)

1

EXPERIMENTAL
Drug: Sorafenib (Nexavar)Drug: Docetaxel

Interventions

Sorafenib (Nexavar)DRUG

Sorafenib 400 mg bid orally continuously Sorafenib will be administered from the start of treatment in combination with Docetaxel until progression of disease.

Also known as: TRATTAMENTO
1
DocetaxelDRUG

Docetaxel 75 mg/mq ev g1 every 21 days. Docetaxel will be administered for a maximum of 9 cycles.

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with metastatic hormone refractory prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dipartimento di Oncologia, dei Trapianti e delle Nuove Tecnologie in Medicina ... Indirizzo: via Roma, 55 - 56100 Pisa Tel. 050-2218690 - Fax. 050-2218685

Pisa, Pisa, 56100, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

SorafenibDocetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 21, 2008

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2009

Last Updated

February 26, 2009

Record last verified: 2009-02

Locations

IT(1)