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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

2 Jun 2024 → ongoing

Decision date (initial)

2024-12-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518035-11-01

EudraCT number

2019-004259-35

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

This is a randomized phase II trial to evaluate biomarkers (Bis(monoacylglycero)phosphate (BMP)) and PSA response rates after combining either docetaxel and ebastine or cabazitaxel and ebastine in castration resistant prostate cancer.

Conditions and MedDRA coding

metastatic castration-resistant prostate cancer (mCRPC)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

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

Exclusion criteria 1

1. 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 A) including over-the-counter medication. 6. Use of other investigational drug 7. Allergic reaction to any of the included drugs

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in blood and urine Bis(monoacylglycero)phosphate (BMP)

Secondary endpoints 1

1. • PSA response rate (≥ 50% decline in PSA compared to baseline according to PCWG3.) • Radiologic progression free survival (rPFS). • Time to PSA progression defined in accordance with PCWG3. • Toxicity in the combination of docetaxel and ebastine.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Blegdamsvej 9

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Helle Pappot

Public contact point

Organisation

Rigshospitalet

Contact name

Helle Pappot

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications