Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer

Trial Title: Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer

NCT ID: NCT06480110

Condition: Metastatic Castration-resistant Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Docetaxel
Ebastine

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Docetaxel + Ebastine
Description: Ebastine is administered once daily.
Arm group label: Intervention

Other name: Kestine (Ebastine)

Intervention type: Drug
Intervention name: Docetaxel
Description: docetaxel every three weeks
Arm group label: Comparator

Summary: This is an open-label phase I/II study evaluating the addition of ebastine to docetaxel in the treatment for metastatic castration resistant prostate cancer. Patients will be randomized in a 2:1 fashion to receive ebastine daily during and after treatment with a maximum of 10 courses of docetaxel. The primary endpoint is change in the profile of urinary and blood lipids to indicate absorption and possible efficacy of ebastine. Secondary endpoints include PSA response and radiologic progression free survival.

Detailed description: The complete study protocol can be studied by contacting the authors.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 1. Have a histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate (carcinomas with pure small-cell histology or pure high grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed). 2. Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL equivalent to 1.7 nmol/L. For patients, currently being treated with luteinizing hormone-releasing hormone (LHRH) agonists, i.e., patients who have not undergone an orchiectomy, therapy must be continued throughout the study. 3. Have evidence of disease progression after prior therapy for mCRPC: Disease progression after initiation of most recent therapy is based on any of the following criteria: - Rise in PSA: a minimum of 2 consecutive rising levels, with an interval of ≥ 1 week between each determination. The most recent screening measurement must have been ≥ 2 ng/mL - Transaxial imaging: new or progressive soft tissue masses on CT or MRI scans as defined by RECIST 1.1 - Radionuclide bone scan: at least 2 new metastatic lesions 4. Signed informed consent obtained prior to initiation of any study-specific procedures or treatment 5. Age ≥ 18 years 6. Life expectancy ≥ 3 months 7. Performance status 0 - 1 8. Adequate organ functions 1. Hematological: absolute neutrophil count (ANC) >1.5 x 109/L, platelet count >100 x 109/L, hemoglobin > 6,2 mmol/L 2. Hepatic: Bilirubin within normal range, aspartate transaminase (AST) and alanine transaminase (ALT) <2.5 upper normal lever, albumin > 25 g/L 3. Renal: creatinine clearance >30 mL/min/1.73m2 Exclusion Criteria: - 1. History of significant gastric or small bowel resection, malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may prevent compliance with oral drug administration 2. Presence of any serious concomitant systemic disorders and/or psychiatric condition incompatible with the study (at the investigator's discretion) 3. Presence of any active infection (at the investigator's discretion). 4. Central nervous system (CNS) disease including epilepsy or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures. 5. Concurrent use of cationic amphiphilic drugs (see appendix A) including over-the-counter medication. 6. Use of other investigational drug 7. Allergic reaction to any of the included drugs

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Oncology 5073, Rigshospitalet

Address:
City: Copenhagen
Zip: 2100
Country: Denmark

Status: Recruiting

Contact:
Last name: Helle Pappot, MD, DMSc

Phone: 0045 35454222
Email: helle.pappot@regionh.dk

Investigator:
Last name: Helle Pappot, MD, DMSc
Email: Principal Investigator

Start date: June 20, 2024

Completion date: December 1, 2027

Lead sponsor:
Agency: Rigshospitalet, Denmark
Agency class: Other

Collaborator:
Agency: Danish Cancer Society
Agency class: Other

Source: Rigshospitalet, Denmark

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06480110