Ebastine in combination with docetaxel as a treatment for castration-resistant metastatic prostate cancer

Phase 1

Conditions: Male patients with metastatic castration resistant prostate cancer
MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2019-004259-35-DK

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 30

Inclusion Criteria

In order to participate in this study, the subjects must meet all of the following 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
a. Hematological: absolute neutrophil count (ANC) >1.5 x 109/L, platelet count >100 x 109/L, hemoglobin > 6,2 mmol/L
b. Hepatic: Bilirubin within normal range, aspartate transaminase (AST) and alanine transaminase (ALT) <2.5 UNL, albumin > 25 g/L
c. Renal: creatinine clearance >30 mL/min/1.73m2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

In order to participate in the study subjects must not meet any of the following 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. 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 B) including over-the-counter medication.
6.Use of other investigational drug
7.Allergic reaction to any of the included drugs

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Examine the combination of docetaxel and ebastine in the treatment of castration resistant prostate cancer.;Secondary Objective: Examine efficacy of combination of docetaxel and ebastine compared to docetaxel alone;Primary end point(s): Change in urine biomarkers; Bis(monoacylglycero)phosphate (BMP);Timepoint(s) of evaluation of this end point: After each treatment a urine sample will be gathered and evaluated

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •PSA response rate (= 50% decline in PSA compared to baseline according to PCWG3.)<br>•Radiologic progression free survival (rPFS).<br>•Time to PSA progression defined in accordance with PCWG3.<br>•Toxicity in the combination of docetaxel and ebastine.<br>;Timepoint(s) of evaluation of this end point: Response rate is evaluated at time of PSA nadir. Radiologic progression free survival at time of radiologic evaluation.<br>Time to PSA progression at time of PSA progression (PSA is measured once every treatment)

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