EUCTR2012-004331-23-DE
Active, not recruiting
Phase 1
A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-Naïve and Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Sponsor
- Janssen-Cilag International NV
- Enrollment
- 164
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Have a histologically or cytologically confirmed adenocarcinoma of the
- •\- Have metastatic disease documented by positive bone scan or by computed tomography or magnetic resonance imaging
- •\- Have prostate cancer progression documented by prostate specific
- •antigen according to Prostate Cancer Working Group 2 or radiographic
- •progression according to modified RECIST (response evaluation criteria
- •in solid tumors, v1\.1\) criteria
- •\-Be asymptomatic from prostate cancer. A score of 0\-1 on BPI\-SF
- •Question \#3 (worst pain in last 24 hours) will be considered
- •asymptomatic
- •\-Be surgically or medically castrated, with testosterone levels of \<50
Exclusion Criteria
- •\-Has a history of pituitary or adrenal dysfunction
- •\-Has an active infection or other medical condition that would
- •contraindicate corticosteroid use
- •\-Has any chronic medical condition requiring corticosteroid treatment or
- •has received prior corticosteroid treatment for prostate cancer
- •\-Has a pathological finding consistent with small cell carcinoma of the
- •\-Has a known brain metastasis
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Abiraterone with Different Steroid Medications Regimens for side effect prevention in [metastatic castrate-resistant] prostate cancer patients prior to chemotherapy treatmentEUCTR2012-004331-23-GBJanssen-Cilag International NV164
Active, not recruiting
Phase 1
Abiraterone with Different Steroid Medications Regimens for side effect prevention in [metastatic castrate-resistant] prostate cancer patients prior to chemotherapy treatmentMetastatic Castration-Resistant Prostate CancerMedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-004331-23-HUJanssen-Cilag International NV144
Active, not recruiting
Phase 1
Abiraterone with Different Steroid Medications Regimens for side effect prevention in [metastatic castrate-resistant] prostate cancer patients prior to chemotherapy treatmentMetastatic Castration-Resistant Prostate CancerMedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-004331-23-BEJanssen-Cilag International NV144
Active, not recruiting
Phase 1
A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-Naïve and Metastatic Castration-Resistant Prostate Cancer (mCRPC) PatientsEUCTR2012-004331-23-ITJanssen-Cilag International NV164
Completed
Phase 1
MAdCaP: MDM2 inhibition and Abiraterone in Carcinoma of the ProstateProstate cancerCancerMalignant neoplasm of prostateISRCTN38949950HS Greater Glasgow and Clyde (UK)132