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Clinical Trials/EUCTR2014-002987-34-GB
EUCTR2014-002987-34-GBActive, not recruitingPhase 1

A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic Pharmacogenetics Blood Sample Amendment Number 01

Bristol-Myers Squibb International Corporation0 sites82 target enrollmentStarted: October 9, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
82
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •- Prostate cancer with metastases
  • •- Prostate cancer should be castration resistant
  • •- Progression during hormonal therapy
  • •Please see protocol for further information on inclusion criteria
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 75
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 175

Exclusion Criteria

  • •- Visceral metastases (eg liver, lung or brain metastases)
  • •- Prior treatment with any immunotherapy for prostate cancer
  • •- Prior or ongoing cytotoxic therapy for prostate cancer
  • •- Autoimmune disease
  • •- Inadequate hematologic, renal, or hepatic function
  • •Please see protocol for further information on exclusion criteria

Investigators

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A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic;Pharmacogenetics Blood Sample Amendment Number 01
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Safety and Efficacy study of ipilimumab 3 mg/kg versus ipilimumab 10 mg/kg in subjects with metastatic castration resistant prostate cancer who are chemotherapy naiveMetastatic Chemotherapy-Naïve Castration Resistant Prostate CancerMedDRA version: 17.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Safety and Efficacy study of ipilimumab 3 mg/kg versus ipilimumab 10 mg/kg in subjects with metastatic castration resistant prostate cancer who are chemotherapy naiveMetastatic Chemotherapy-Naïve Castration Resistant Prostate CancerMedDRA version: 17.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2014-002987-34-NLBristol-Myers Squibb International Corporation250