Know Cancer

forgot password

A Phase 2 Open-label Extension Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100

Phase 2
18 Years
Open (Enrolling)
Castration-Resistant Prostate Cancer (CRPC)

Thank you

Trial Information

A Phase 2 Open-label Extension Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100

This is a multi-center extension study in subjects with prostate cancer who have completed
MDV3100 treatment study 9785-CL-0007 to assess the long-term safety of continued
administration of MDV3100, when judged by the investigator to be in the best interest of the

For the study duration, all subjects with castration-resistant prostate cancer (CRPC) will
have to maintain androgen deprivation with a Luteinizing Hormone Releasing Hormone (LHRH)
agonist/antagonist unless they underwent bilateral orchiectomy.

Subjects will be discontinued from study drug when continued administration of study drug is
deemed to be not in the subject's best interest by the investigator based on clinical

Throughout the study, safety and tolerability will be assessed by the recording of adverse
events, monitoring of vital signs and physical examinations, safety laboratory evaluations,
and 12-lead electrocardiograms (ECGs).

Subjects will have a safety follow-up visit 30 days after their last dose of study drug.

Inclusion Criteria:

- Has completed a prior study with MDV3100, can be enrolled in this extension study
without any interruption in study drug

- No new clinically significant abnormalities based upon physical examination, safety
laboratory data, vital signs, ECG, and other clinical assessments noted from the last
visit conducted during the subject's active MDV3100 study prior to initiation of this

- Sexually active male subject must be non-fertile, i.e., surgically sterilized or must
practice an adequate contraceptive method to prevent pregnancies. Adequate
contraceptive methods are defined as:

- sexual abstinence from the day of dosing until 3 months after the last dose;

- the use of a condom or having their partner use another acceptable method (oral
or injectable hormonal contraceptives, contraceptive patch, intra-uterine
devices, vaginal hormonal rings, or sterilization by surgery, a vaginal
diaphragm or cervical caps) during the study and for 3 months after the last

- subject's sexual partner is of non-child bearing potential (i.e., post
menopausal, surgically sterilized (e.g., tubal ligation) hysterectomy)

Exclusion Criteria:

- Use of the following prohibited medication/therapies:

- Concomitant medication that likely could cause clinically relevant drug-to-drug
interactions with MDV3100

- Other (than MDV3100) androgen-receptor (AR) antagonists (bicalutamide,
flutamide, nilutamide)

- Investigational therapy other than MDV3100 or investigational procedures of any

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Long term safety of continued administration of MDV3100 through assessment of adverse events, vital signs, ECGs, physical examinations and laboratory evaluations

Outcome Time Frame:

Until Subject Discontinuation (up to 5 years)

Safety Issue:


Principal Investigator

Clinical Study Manager

Investigator Role:

Study Chair

Investigator Affiliation:

Astellas Pharma Europe B.V.


South Africa: Medicines Control Council

Study ID:




Start Date:

November 2011

Completion Date:

December 2022

Related Keywords:

  • Castration-Resistant Prostate Cancer (CRPC)
  • Prostate Cancer
  • Castration-Resistant Prostate Cancer (CRPC)
  • MDV3100
  • Androgen receptor signaling inhibitor
  • Prostatic Neoplasms