Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
44
Countries
1
Sites
4
Advanced prostate cancer
To evaluate the efficacy of a dosing regimen of teverelix DP in attaining by Day 29 and sustaining to Day 155 castration rate defined as the cumulative probability of testosterone suppression to < 0.5 ng/mL with the lower bound of the 95% confidence interval (CI) being > 90%
Key facts
- Sponsor
- Antev Limited, Antev Nordic AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-04-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Antev Ltd.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacodynamic, Pharmacokinetic, Therapy
To evaluate the efficacy of a dosing regimen of teverelix DP in attaining by Day 29 and sustaining to Day 155 castration rate defined as the cumulative probability of testosterone suppression to < 0.5 ng/mL with the lower bound of the 95% confidence interval (CI) being > 90%
Secondary objectives 1
- To evaluate the ability of a dosing regimen of teverelix DP in attaining by Day 29 and sustaining to Day 155 profound castration rate defined as the cumulative probability of testosterone suppression to < 0.2 ng/mL
Conditions and MedDRA coding
Advanced prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Teverelix DP single-arm, open-label, multi-centre This is a single-arm, open-label, multi-centre trial where all trial participants will receive the same treatment of 540 mg teverelix DP (loading dose) on Day 1 and 360 mg teverelix DP (maintenance dose) on Days 29; 71; 113 and 155
|
Not Applicable | None |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- not sure yet
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509255-14-00 | A Phase 2, Open-Label, Single-Arm, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Participants with Advanced Prostate Cancer | Antev Limited |
| 2023-505535-13-00 | A Phase 2, Open-Label, Single-Arm, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Participants with Advanced Prostate Cancer | Antev Limited |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- (1) Is male, aged ≤85 years (≥18 years) at the beginning of the treatment period (Day 1) (2) Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non- metastatic, hormone-sensitive, non-curative), suitable for androgen deprivation therapy (3) Is treatment naïve for GnRH analogues
Exclusion criteria 1
- (1) Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values: (a) Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), exceeding >2X the upper limit of the normal (ULN) range (b) Total bilirubin exceeding >1.5X the upper limit of the normal (ULN) range (c) Creatinine twice the ULN range (d) Uncontrolled diabetes (HbA1c >7.5%) or previously undiagnosed diabetes mellitus with HbA1c >6.5% (e) An estimated glomerular filtration rate (eGFR) < 30 mL/min, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalized to an average surface area of 1.73m2, at the screening visit. (2) Has any contraindication to the use of teverelix DP (3) Has a life expectancy of less than 1 year (4) Has T levels <1.5 ng/mL at screening (5) Has a medical history of bilateral orchidectomy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The sustained castration rate defined as the cumulative probability of achieving testosterone suppression to castrate levels of ≤ 0.5 ng/mL (1.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155
Secondary endpoints 1
- The sustained castration rate, defined as the cumulative probability of testosterone suppression to ≤ 0.2 ng/mL (0.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10625711 · Product
- Active substance
- Teverelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PARENTERAL
- Max daily dose
- 10.5 mg milligram(s)
- Max total dose
- 1620 mg milligram(s)
- Max treatment duration
- 22 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ANTEV LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Antev Limited
- Sponsor organisation
- Antev Limited
- Address
- 106 New Bond Street
- City
- London
- Postcode
- W1S 1DN
- Country
- United Kingdom
Scientific contact point
- Organisation
- Antev Limited
- Contact name
- Carol Marion MacLean
Public contact point
- Organisation
- Antev Limited
- Contact name
- Carol Marion MacLean
Antev Nordic AB
- Sponsor organisation
- Antev Nordic AB
- Address
- Per Albin Hanssons Vag 41, Fosie Fosie
- City
- Malmo
- Postcode
- 214 32
- Country
- Sweden
Sponsor responsibilities
- Contact point sponsor
- Antev Limited
- Article 77 implementation
- Antev Limited
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Lithuania | Authorised, recruitment pending | 44 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Urology, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Urology, Eiveniu G. 2, Kauno M. Sav., Kaunas
Nacionalinis vezio institutas
Urology, Santariskiu G. 1, Vilniaus M. Sav., Vilnius
Klaipedos universiteto ligonine VšĮ
Urology, Liepojos G. 41, Klaipedos M. Sav., Klaipeda
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Lithuania |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol_2023-509255-14-01_REDACTED | 2 |
| Protocol (for publication) | D1_protocol_2023-509255-14-01_REDBOX | 2 |
| Recruitment arrangements (for publication) | K1_ANT-1111-05_Recruitment-Arrangements_LTU_11Jul2023_Public | 1 |
| Recruitment arrangements (for publication) | K2_ANT-1111-05_Recruitment-Process_LTU_Lithuanian_11Jul2023_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_V2_LT_24Apr2024_clean | 2 |
| Subject information and informed consent form (for publication) | L2_ANT-1111-05_Patient Card_LTU_Lithuanian_v1_0_11Jul2023_Public | 1 |
| Synopsis of the protocol (for publication) | D1 _Protocol synopsis_2023-509255-14-01 _V2_24Apr2024_LT | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-06 | Lithuania | Acceptable 2024-04-02
|
2024-04-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-29 | Lithuania | Acceptable 2024-06-11
|
2024-07-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-19 | Lithuania | Acceptable 2026-01-21
|
2026-01-21 |