Sodium selenite in patients with advanced carcinoma: SECAR 1c

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

17 Apr 2026 → ongoing

Decision date (initial)

2025-12-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Sjöbergstiftelsen · Cancerfonden · Cancerföreningen i Stockholm · Cancer-och Allergifonden

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

The primary objective of this trial is to find the optimal dose for tolerability and efficacy of a 99 h long intravenous selenite treatment. That is the dose measured as mg/m2/99hours, resulting in the best clinical responses (PR+CR) without dose limiting toxicities.

Secondary objectives 7

1. To evaluate clinical responses after chemotherapy in patients that have received selenite treatment
2. To evaluate the effect of selenite and chemotherapy treatment on the improvement of disease symptoms.
3. To investigate the pharmacokinetics of selenium and selenite and analyse its relationship with clinical responses.
4. To determine the relationship between plasma levels of selenite to responses and AE’s.
5. To determine the relationship between levels of selenite in erythrocytes and responses and AE’s respectively
6. To study the effect of the selenite treatment on cytokines and lymphocytes
7. To evaluate the effect of selenite and chemotherapy treatment on survival

Conditions and MedDRA coding

Advanced carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Advanced malignant disease, stage III or IV.
2. Histologically or cytologically verified tumor.
3. Progressing tumor despite earlier treatment with all standard of care treatments for respective tumor
4. WHO performance status 0, 1 and 2.
5. 18 or more years of age.
6. Radiation therapy or chemotherapy should not have been given for a t least 3 weeks before start of selenite.
7. The patient must accept to give blood and urine samples for routine and for research purposes.
8. Written informed consent.
9. The patient must accept that the study treatment and the follow-ups within the study are performed at the phase 1 unit at Tema Cancer, Karolinska University Hospital.
10. A female participant is eligible for this study if she is one of the following: • of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, or infertile due to previous chemotherapy) • of childbearing potential but agrees to practice highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) Highly effective methods of contraception include one or more of the following: a. male partner who is sterile (vasectomized) prior to the female study subject’s entry into the study and is the sole sexual partner for the female subject; b. hormonal (oral, intravaginal, transdermal, implantable or injectable) c. an intrauterine hormone-releasing system (IUS) d. an intrauterine device (IUD) with a documented failure rate of < 1%.

Exclusion criteria 12

1. Dysfunction of heart (NYHA ≥2), kidney (cystatinC >1.60, if on limit Pt-eGFR<50), liver (bilirubin > 30) or other organs that might give a considerable increased risk for patient safety.
2. Impaired ability to cooperate.
3. The tumor size not possible to measure
4. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
5. Ongoing treatment with antidepressants other psychotropic drugs that may cause confusion. The drug must be stopped at least 3 weeks before starting selenite treatment.
6. Medical history of obstacle in the pharynx giving risk for aspiration pneumonia if vomiting.
7. Brain metastases giving symptoms and symptomless brain metastases localised in the pons region. CT or MRI of the brain, not older than 6 weeks before start of treatment must be free from metastases. Patients with treated brain metastases (irradiation or surgery) and free from symptoms can be included.
8. Patients with known HIV/AIDS or hepatitis B/C with respect to increased risks for scientists working with research blood samples.
9. Allergies against previously used chemotherapy.
10. Pregnant or breast-feeding women
11. Patients with reproductive potential not implementing accepted and effective means of contraception.
12. Cancer-treatment within the previous 3 weeks. The patient can be included when 3 weeks have past since the latest treatment if still fulfilling all other criteria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The optimal dose, i.e., the dose with the best clinical response without DLT. Clinical response will be evaluated using RECIST 1.1 on CT scans taken before and after the selenite treatment. Toxicity will be measured according to the CTCAE V4.0 system (as in previous SECAR studies, to allow for direct comparisons).

Secondary endpoints 7

1. Tumor response to chemotherapy following selenite treatment as evaluated using RECIST 1.1 on CT scans taken before and after chemotherapy.
2. Improvement of disease symptoms as measured by improvement in WHO performance status assessed before, during and after treatments
3. Improvement of disease symptoms according to tumour markers or improvement of other abnormal laboratory results measured before, during and after treatments.
4. Description of the pharmacokinetics of selenium and selenite. Plasma, erythrocytes and urine for these analyses will be collected before, during and after the selenite infusion.
5. Correlation between plasma levels and erythrocyte levels of selenite and clinical responses and AE’s.
6. The effect of high dose selenite-infusion on immunological variables
7. Overall survival as measured from the first selenite treatment day until death of any cause.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

Sponsor organisation

Karolinska University Hospital

Address

Eugeniavagen 3

City

Solna

Postcode

171 64

Country

Sweden

Scientific contact point

Organisation

Karolinska University Hospital

Contact name

Ola Brodin

Public contact point

Organisation

Karolinska University Hospital

Contact name

Ola Brodin

Locations

1 EU/EEA country · 1 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 6 files

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

Application history

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