The evaluation of the effectiveness, safety and tolerability of treatment, using a specialized prostate-specific membrane antigen (PSMA) labeled with Lutetium177, in patients with recurrent and/or metastatic adenoid cystic carcinoma originating from the salivary glands - an open, non-commercial clinical trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

completed 3 Apr 2025

Decision date (initial)

2023-09-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Agencja Badań Medycznych (project ABM No. 2021/ABM/03/00016)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Assessment of safety and tolerability of treatment according to Common Terminology Criteria for Adverse Events (CTCAE v. 5.0)

Secondary objectives 1

1. Assessments of the following: 1.Objective response rate (ORR) – assessment in CT scan according to RECIST 1.1 score – 2 years after completion of the treatment, 2.Progression free survival (PFS) - assessed from the start of treatment to the time of disease progression or death, 3.Overall survival (OS) – assessed from the start of treatment to the time of death, 4.Duration of response (DoR) – assessed from inclusion in the study to the time of progression or death in patients who achieved a complete or partial response - only patients in remission will have this parameter assessed, 5.Quality of life assessment (according to EORTC QLQ-C30 and EORTC QLQ-H&N43 questionnaires) – assessed from enrollment in the study to 2 years after completion of the treatment

Conditions and MedDRA coding

Adenoid cystic carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Giving written informed consent to participate in the study.
2. Patients with unresectable, locoregionally advanced or metastatic, histopathologically proven Adenoid Cystic Carcinoma of salivary glands.
3. Age over 18 years.
4. WHO Performance Status 0 to 2.
5. 68Ga-PSMA PET/CT proven expression of PSMA; a positive result is considered as a qualitative assessment equal or greater than accumulation in functional liver.
6. Progression of disease confirmed by imaging scans according to RECIST 1.1 criteria.
7. Adequate function of: Bone marrow - neutrophils >1500x109/L; thrombocytes >150 000x109/L, hemoglobin >9 g/dl; Liver - bilirubin <2xULN (upper limit of normal range); aminotransferase <3xULN (patients with liver metastases <5xULN); Kidneys - eGFR >50 ml/min; Albumins >2,5 mg/ml
8. In women with procreative ability: confirmed negative pregnancy test result and consent to the implementation of double barrier contraception method.
9. In men with procreative ability: consent to the implementation of double barrier contraception method.

Exclusion criteria 7

1. Pregnancy or breastfeeding.
2. Lack of effective contraception in childbearing age.
3. Patients with brain, cerebral meninges or heart metastases.
4. Severe or significant concomitant disease in the investigator's assessment.
5. Urinary tract obstruction or/and hydronephrosis.
6. Concurrent anticancer treatment.
7. Myelosuppressive or nuclear treatment within 4 weeks before enrollment to the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Assessment of safety and tolerability of treatment according to Common Terminology Criteria for Adverse Events (CTCAE v. 5.0)

Secondary endpoints 5

1. Objective response rate (ORR) – assessment in CT scan according to RECIST 1.1 score – 2 years after completion of the treatment
2. Progression free survival (PFS) - assessed from the start of treatment to the time of disease progression or death
3. Overall survival (OS) – assessed from the start of treatment to the time of death
4. Duration of response (DoR) – assessed from inclusion in the study to the time of progression or death in patients who achieved a complete or partial response - only patients in remission will have this parameter assessed
5. Quality of life assessment (according to EORTC QLQ-C30 and EORTC QLQ-H&N43 questionnaires) – assessed from enrollment in the study to 2 years after completion of the treatment

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Sponsor organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Address

Ul. Wybrzeze Armii Krajowej 15

City

Gliwice

Postcode

44-102

Country

Poland

Scientific contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Contact name

Centrum Wsparcia Badań Klinicznych

Public contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Contact name

Centrum Wsparcia Badań Klinicznych

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Sponsor organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Address

Ul. Wybrzeze Armii Krajowej 15

City

Gliwice

Postcode

44-102

Country

Poland

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

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