An open-label, multi-center, phase I/II study of MFA-370 in patients with metastatic urothelial cancer

Phase 1

• Conditions: Metastatic urothelial cancer; MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000068-30-DK
• Lead Sponsor: Ectin Research AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-03
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Signed Informed Consent Form before any screening procedures
2. = 18 years of age on the day of giving informed consent
3. Confirmed current metastatic urothelial carcinoma of the bladder, including the urethra and upper urinary tract. The patient needs to have progressive disease and/or symptomatic metastatic disease that is unresponsive to standard therapy. The patient must have received all available approved therapies before being eligible for the study unless contraindications or intolerance exist for one or several of them
4. At least one lesion of measurable disease as defined by RECIST1.1 criteria based on CT or MRI scan made within 2 weeks before ibuprofen-start at Day -7
5. World Health Organization (WHO) performance status 0-2
6. Life expectancy =12 weeks
7. Patients with reproductive potential will need to use accepted and highly effective means of contraception from study entry until at least 6 weeks for females (women of childbearing potential, WOCP) and 3 months for males after study drug discontinuation
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

1. Known CNS metastatic lesions, or evidence of impaired blood-brain barrier as assessed by the investigator
2. Have signs or symptoms of active COVID-19 infection or a positive COVID-19 PCR test during the screening period
3. Impaired renal function by estimated Glomerular Filtration Rate (eGFR) <30 ml/min as per local assessment
4. Laboratory values (hematology and biochemistry) within specified ranges to show appropriate organ function
5. Clinically significant cardiac disease,
6. Untreated or uncontrolled hypertension
7. An underlying medical condition that precludes the ability to take oral medication daily
8. Concomitant therapy that precludes enrolment:
• Concomitant use of other nonsteroidal anti-inflammatory drugs (NSAIDs). Wash out and change of treatment is allowed during the screening period and up to one week before visit 2
• Treatment in a prior investigational study within four weeks before enrolment or within five half-lives of the investigational product, whichever is longer, before starting study drug (visit 2)
9. The patient has had biologic, hormonal, anti-neoplastic chemotherapy within 4 weeks prior to screening except for medications with half-lives <5.5 days, or radiation therapy other than palliative treatment within 2 weeks
10. Hypersensitivity to ibuprofen, ivermectin, avermectin, or any of the excipients listed in section 6.1 in respective SmPC
11. Any bleeding disorder or condition where there is an increased risk of bleeding
12. A history of allergic reactions following intake of acetylsalicylic acid or NSAIDs
13. A history of gastrointestinal bleeding or perforation
14. Active or recurrent gastrointestinal ulcer
15. The known or suspected presence of a tropical parasitic infection, such as strongyloidiasis, onchocerciasis, or any other for which treatment with ivermectin is indicated
16. Major surgery within 14 days before enrolment. (Note: trans-urethral resection of bladder tumor is not considered major surgery)
17. For female patients of childbearing potential – pregnancy, as confirmed by a serum pregnancy test at screening, or breast-feeding
18. Any other severe, acute, or chronic medical condition that would interfere with the conduct of the study or interpretation of the study results as judged by the investigator
19. The patient has already participated in the study or been a screening failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified