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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

‣ Hematological: absolute neutrophil count (ANC) \>1.5 x 109/L, platelet count \>100 x 109/L, hemoglobin \> 6,2 mmol/L

⁃ Hepatic: Bilirubin within normal range, aspartate transaminase (AST) and alanine transaminase (ALT) \<2.5 upper normal lever, albumin \> 25 g/L

⁃ Renal: creatinine clearance \>30 mL/min/1.73m2

Locations
Other Locations
Denmark
Department of Oncology 5073, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Helle Pappot, DMsc
helle.pappot@regionh.dk
+4535458403
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 30
Treatments
Experimental: Intervention
Standard docetaxel (10 cycles) plus ebastine daily
Active_comparator: Comparator
Standard docetaxel (10 cycles) without ebastine
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark
Collaborators: Danish Cancer Society

This content was sourced from clinicaltrials.gov

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