You are here

Our science / Clinical Trials / Find a Trial / NCT00510718

A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer

Back to Search Print Save as PDF Bookmark Trial

NCT00510718

Last updated on December 5, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02115 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer, Hormone Refractory Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Histologically or cytologically confirmed adenocarcinoma of the prostate;

2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH)
analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);

3. Progressive disease after medical or surgical castration,

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Metastases in the brain or active epidural disease. (Note: patients with treated
epidural disease are allowed);

NCT00510718
Pfizer
Completed
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Advanced Search

Similar Trials

Advanced Breast Cancer, Metastatic Breast Cancer
Palbociclib in Real World Practice
NCT03280303
All Genders
18+
Years
Multiple Sites
Advanced or Recurrent Solid Tumors, Breast Neoplasms, Epithelial Ovarian Cancer, Ewing Sarcoma, Small Cell Lung Carcinoma, Prostate Cancer, Pancreas Cancer
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
NCT01286987
All Genders
18+
Years
Multiple Sites
Metastatic Cancer Pancreas
Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
NCT02109445
All Genders
18+
Years
Multiple Sites
ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
NCT01970865
All Genders
18+
Years
Multiple Sites
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
A Phase 1, Open-label, Dose-escalation Safety And Pharmacokinetic Study Of Mdv3100 In Patients With Castration-resistant Prostate Cancer
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • Prostate Cancer
  • Hormone Refractory Prostate Cancer
Drug: MDV3100
MDV3100 daily until progression or dose-limiting toxicity
Other Names:
  • enzalutamide
  • Xtandi
Experimental: 1
MDV3100
Intervention: Drug: MDV3100


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
January 2018
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate;
  2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
  3. Progressive disease after medical or surgical castration,

Exclusion Criteria:

1. Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00510718
S-3100-1-01
C3431009 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now