A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
NCT ID: NCT01284920
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
47 participants
INTERVENTIONAL
2010-11-02
2014-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dose-escalation cohort-1
MDV3100 low dose arm
MDV3100
oral
dose-escalation cohort-2
MDV3100 middle dose arm
MDV3100
oral
dose-escalation cohort-3
MDV3100 high dose arm
MDV3100
oral
dose-expansion cohort
dose expansion with MDV3100 middle dose
MDV3100
oral
Interventions
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MDV3100
oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
MALE
No
Sponsors
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Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Chugoku, , Japan
Chūbu, , Japan
Hokkaido, , Japan
Kansai, , Japan
Kanto, , Japan
Kyusyu, , Japan
Shikoku, , Japan
Countries
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References
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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.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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9785-CL-0111
Identifier Type: -
Identifier Source: org_study_id
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