A Phase I-IIa, open-label, single-center, dose-escalating study to evaluate the safety, pharmacokinetics and pharmacodynamics of intravenous pegylated liposomal dexamethasone sodium phosphate as monotherapy in patients with castration-resistant metastatic prostate cancer

Enceladus Pharmaceuticals (Netherlands)0 sites9 target enrollmentJanuary 2, 2020

ConditionsCastration-resistant metastatic prostate cancer Cancer Malignant neoplasm of prostate

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Castration-resistant metastatic prostate cancer
Sponsor: Enceladus Pharmaceuticals (Netherlands)
Enrollment: 9
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34414692/ (added 23/08/2021)

Registry

who.int

Start Date

January 2, 2020

End Date

August 9, 2019

Last Updated

4 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Enceladus Pharmaceuticals (Netherlands)

Eligibility Criteria

Inclusion Criteria

•1\. Adult patients with mCRPC and one or more metastases in the bone, confirmed by bone scintigraphy, MRI or CT\-scan within 6 weeks before first dosage
•2\. Able to participate, and willing to give written informed consent and to comply with the study restrictions
•3\. Body mass index (BMI) of 18 kg/m2 or higher (inclusive) and a minimum weight of 50 kg
•4\. Not yet, or no longer eligible for other, registered therapy other than glucocorticoids
•5\. Live expectancy in good clinical condition (WHO 0\-1\) for more than 3 months

Exclusion Criteria

•1\. Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient
•2\. Contraindication for glucocorticoids as judged by clinician or investigator
•3\. Use of systemic glucocorticosteroids within 4 weeks before first dosage, with exception of topical and inhalation steroids
•4\. Any confirmed and clinically significant allergic reactions (urticaria or anaphylaxis, non\-active hay fever is acceptable). Allergy or hypersensitivity against any drug, including any component of the study drug, biologic therapy or IV radiocontrast agent
•5\. Clinically significant abnormalities, as judged by the investigator, following a detailed medical history, a physical examination including vital signs, 12\-lead ECG and laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant
•6\. History or symptoms of any significant disease including (but not limited to) neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may aggravate due to study participation and jeopardize the health status of the patient
•7\. Any infection within 1 month prior to drug administration
•8\. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
•9\. History of alcohol or substance abuse
•10\. Use of CYP3A4\-inhibiting drugs or food (grapefruit, grapefruit juice, grapefruit\-containing products, Seville oranges, or pomelo\-containing products, and quinine containing drinks within 14 days prior to dosage