NCT00385580

Brief Summary

The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2007

Geographic Reach
3 countries

11 active sites

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

First Submitted

Initial submission to the registry

October 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 1, 2011

Completed
Last Updated

April 30, 2013

Status Verified

October 1, 2012

Enrollment Period

1.9 years

First QC Date

October 4, 2006

Results QC Date

October 7, 2010

Last Update Submit

April 24, 2013

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With a Response

    Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =\>30% in sum of longest diameter \[LD\] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease \[PD: =\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors \[RECIST\].

    Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.

  • Percentage of Participants With a Response

    Response = confirmed PSA response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=\>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD \[=\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on RECIST.

    Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.

Secondary Outcomes (38)

  • Number of Participants With a Decrease in PSA by at Least 50% From Baseline

    Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

  • Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline

    Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

  • Number of Months of Decrease in PSA by at Least 50% From Baseline

    Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

  • Number of Participants With Decrease in PSA Velocity

    Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

  • Number of Participants With Decrease in PSA Log Slope

    Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

  • +33 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: dasatinib

2

EXPERIMENTAL
Drug: dasatinib

Interventions

dasatinibDRUG

Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression

Also known as: Sprycel, BMS-354825
1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males, 18 or older
  • proven advanced prostate cancer
  • documented metastatic disease
  • rising PSA levels
  • castrate levels of testosterone

You may not qualify if:

  • symptomatic CNS (brain or spinal cord) metastasis
  • medical condition which may increase the risk of toxicity
  • any prior or ongoing anti-cancer medical therapy or immunotherapy for prostate cancer other than primary androgen deprivation agents
  • unable to take oral medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

The Bunting Blaustein Cancer Research Building

Baltimore, Maryland, 21231, United States

Location

Memorial Sloan-Kettering Cancer Center-Sidney Kimmel Center

New York, New York, 10021, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr

Madison, Wisconsin, 53792, United States

Location

Local Institution

Montpellier, 34298, France

Location

Local Institution

Paris, 75015, France

Location

Local Institution

Villejuif, 94800, France

Location

Local Institution

Rome, 00152, Italy

Location

Related Publications (1)

  • Yu EY, Wilding G, Posadas E, Gross M, Culine S, Massard C, Morris MJ, Hudes G, Calabro F, Cheng S, Trudel GC, Paliwal P, Sternberg CN. Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Dec 1;15(23):7421-8. doi: 10.1158/1078-0432.CCR-09-1691. Epub 2009 Nov 17.

    PMID: 19920114BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Results Point of Contact

Title
BMS Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 9, 2006

Study Start

January 1, 2007

Primary Completion

December 1, 2008

Study Completion

October 1, 2010

Last Updated

April 30, 2013

Results First Posted

March 1, 2011

Record last verified: 2012-10

Locations

FR(3)US(7)IT(1)