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A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer

Phase 1/Phase 2
20 Years
Open (Enrolling)
Prostate Neoplasms, Prostate Cancer, Castration Resistant Prostate Cancer (CRPC)

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Trial Information

A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer

This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where
dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in
metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort,
where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be
evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts,
additional patients are included in Expansion Cohort.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy

- Progressive disease after prior androgen deprivation therapy (medical or surgical

- For Expansion Cohort, the patient has no more than two prior chemotherapy regimens
with at least one regimen containing docetaxel

- For Expansion Cohort, the patient must have measurable lesions by RECIST

Exclusion Criteria:

- Metastases in the brain

- History of another malignancy except for adenocarcinoma of the prostate within the
previous 5 years

- Use of bicalutamide within 6 weeks prior to study

- Radiation therapy within 12 weeks prior to study

- Evidence of serious drug hypersensitivity

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC

Outcome Description:

This measure will be assessed on the dose escalation cohorts.

Outcome Time Frame:

3 months during the study

Safety Issue:


Principal Investigator

Use Central Contact

Investigator Role:

Study Chair

Investigator Affiliation:

Astellas Pharma Inc


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

November 2010

Completion Date:

December 2013

Related Keywords:

  • Prostate Neoplasms
  • Prostate Cancer
  • Castration Resistant Prostate Cancer (CRPC)
  • MDV3100
  • Response Evaluation Criteria in Solid Tumor (RECIST)
  • docetaxel
  • PSA level
  • Neoplasms
  • Prostatic Neoplasms