Clinical trial NCT01284920: A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
Official title: A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Prostate Neoplasms
Castration Resistant Prostate Cancer (CRPC)
Keywords: docetaxel
Response Evaluation Criteria in Solid Tumor (RECIST)
PSA level
MDV3100
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
First posted: 2011-01-27
Enrollment: 47
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.

Detailed description: 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.

Eligibility criteria: 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 castration)
* 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

Primary outcomes:
measure: Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC
timeFrame: 3 months during the study
measure: Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Day 85 and end of long term dosing period
Secondary outcomes:
measure: Prostate Specific Antigen (PSA) Response
timeFrame: Day 85 and end of long term dosing period
measure: Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG
timeFrame: 3 months during the study
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Akaza H, Uemura H, Tsukamoto T, Ozono S, Ogawa O, Sakai H, Oya M, Namiki M, Fukasawa S, Yamaguchi A, Uemura H, Ohashi Y, Maeda H, Saito A, Takeda K, Naito S. A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer. Int J Clin Oncol. 2016 Aug;21(4):773-782. doi: 10.1007/s10147-016-0952-6. Epub 2016 Jan 21.