NL-OMON44408
Completed
N/A
A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer - DDI Study With JNJ-56021927 and Abiraterone Acetate in Prostate Cancer
Johnson & Johnson Pharmaceutical0 sites10 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- prostate cancer
- Sponsor
- Johnson & Johnson Pharmaceutical
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Men \>\= 18 years of age or older (inclusive).;2\. Eastern Cooperative Oncology Group (ECOG) performance status \<\=2;3\. Histologically or cytologically confirmed adenocarcinoma of the prostate.;4\. Metastatic disease documented by positive bone scan, or visceral metastasis, or lymph;node disease documented on CT or MRI scans;5\. Prostate cancer progression documented by PSA progression according to;PCWG2 or by appearance of new bone lesions on radionuclide bone scan;according to PCWG2 or by radiographic progression according to mRECIST 1\.1;6\. Surgically or medically castrated, with testosterone levels of \< 50 ng/dL (\< 1\.7 nM). If;the subject is being treated with GnRH analogs (subject who has not undergone bilateral;orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study;7\. Resolved any acute toxicity to Grade \<\=1 (except alopecia or Grade \<\= 2 neuropathy) due;to prior chemotherapy or radiotherapy;8\. Bone sparing therapies (eg, bisphosphonates, denosumab) usage is allowed if subjects;are on a stable dose for at least 4 weeks prior to Cycle 1, Day 1;9\. Adequate bone marrow and organ function defined as: Hemoglobin \>\=9\.0 g/dL, independent of transfusion and/or growth factor support; ANC count \>\=1,500 cells/mm3 independent of growth factor support within the prior 3 months; Platelet count \>\=75,000/µL independent of transfusion and/or growth factor;support within the prior 3 months; Serum albumin \>\=3\.0 g/dL;Serum creatinine \<1\.5 × upper limit of normal (ULN) or calculated creatinine;clearance \>\= 50 mL/min/1\.73m2; Serum potassium \>\= 3\.5 mmol/L; Total bilirubin \< 1\.5 × ULN (Subjects with Gilbert\*s Syndrome may be enrolled;if the total bilirubin is \< 3 mg/dL with predominance of indirect bilirubin); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<\= 2\.5 ×;ULN; Electrocardiogram showing QTc \<\= 480 msec;10\. Any number of prior hormonal interventions \[including 1st generation antiandrogens;(flutamide, bicalutamide, nicalutamide), CYP17 inhibitors (eg AA), 2nd generation;androgen antagonists (e.g. enzalutamide), steroids, estrogens, finasteride, dutasteride];for PC are allowed. These therapies, except for GnRH analogs, must have been;discontinued for minimally 4 weeks before first dose of study drug. Enzalutamide must;have been discontinued for minimally 8 weeks before first dose of study drug.;11\. Ability to swallow study drug whole as a capsule/tablet;12\. A man who is heterosexually active with a woman of childbearing potential must agree;to use a double barrier method of birth control such as a condom along with another;effective contraceptive method \[partner using occlusive cap (diaphragm or;cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, contraceptive pill, contraceptive patch, IUD, tubal ligation or status post hysterectomy)]. All men;must also not donate sperm during the study and for 3 months after receiving the last;dose of study drug;13\. Each subject must sign an informed consent document indicating that they understand;the purpose of and procedures required for the study and are willing to participate in the;study
Exclusion Criteria
- •Any potential subject who meets any of the following criteria will be excluded from participating;in the study.;1\. Known brain metastases;2\. Pathological finding consistent with small cell carcinoma of the prostate;3\. Administration of an investigational agent within 4 weeks of Cycle 1 Day 1;4\. Chemotherapy, or immunotherapy for the treatment of PC within 4 weeks of Cycle 1 day 1;5\. Therapies that must be discontinued or substituted at least 4 weeks prior to Cycle 1 Day 1 include the following: Medications known to lower the seizure threshold (see Section 8\.3\); Herbal and non\-herbal products that may decrease PSA levels (ie, saw palmetto, pomegranates or pomegranate juice); Medications known to induce drug metabolizing enzymes such as dexamethasone, rifampicin, carbamazepine, phenytoin, phenobarbital, St. John\*s;wort, etc. (see Section 8\.3\); Potent inhibitors of CYP3A4 (see Section 9\.3\);6\. Subjects currently treated with spironolactone;7\. Subject has known allergies, hypersensitivity, or intolerance to prednisone or the excipients of prednisone, AA or JNJ\-56021927 (refer to Investigator's Brochures for AA and JNJ\-56021927 and package insert for Prednisone) ;8\. Known hypersensitivity to Vitamin E;9\. History of seizures or presence of a condition that may pre\-dispose to seizure (eg, prior;stroke within 1 year prior to Cycle 1 Day 1, brain arteriovenous malformation,Schwannoma, meningioma, or other benign CNS or meningeal disease, which may require treatment with surgery or radiation therapy);10\. Any prior malignancy (other than adequately treated basal cell or squamous cell skin;cancer, superficial bladder cancer, or any other cancer in situ currently in complete;remission) within 3 years prior to Cycle 1 Day 1;11\. History or evidence for any of the following: severe or unstable angina or myocardial;infarction within 12 months prior to Cycle 1 Day 1, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), clinically significant;ventricular arrhythmias or New York Heart Association (NYHA) Class III to IV heart disease;12\. Presence of uncontrolled hypertension (systolic BP \>\= 160 mmHg or diastolic BP \>\= 100;mmHg). Subjects with a history of hypertension are allowed, provided that BP is;controlled to within these limits by anti\-hypertensive treatment;13\. Presence of gastrointestinal disorder affecting absorption;14\. History or evidence for adrenal insufficiency or hyperaldosteronism;15\. Active infection (eg, human immunodeficiency virus \[HIV] or viral hepatitis) or other;medical condition that would make prednisone (corticosteroid) use contraindicated;16\. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg;prednisone daily within 4 weeks prior to Cycle 1 Day 1 and up to Cycle 2 Day 8;17\. Subject has any condition for which, in the opinion of the investigator, participation;would not be in the best interest of the subject (eg, compromise the well\-being) or that;could prevent, limit, or confound the protocol\-specified assessments;18\. Subject is an employee of the investigator or study site, with direct involvement in the;proposed study or other studies under the direction of that investigator or study site, as;well as family members of the employees or the investigator.
Outcomes
Primary Outcomes
Not specified
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