Status:
WITHDRAWN
A Study of MFA-370 in Patients with Metastatic Urothelial Cancer
Lead Sponsor:
Ectin Research AB
Conditions:
Metastatic Urothelial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multi-center study of MFA-370 in patients with metastatic urothelial cancer. The objective of the study is to assess the safety and efficacy of MFA-370, i.e.a combination of two approved pha...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form before any screening procedures
- ≥ 18 years of age on the day of giving informed consent
- 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
- At least one lesion of measurable disease as defined by RECIST1.1 criteria based on CT or MRI scan within 2 weeks before start at Day -7
- World Health Organization (WHO) performance status 0-2
- Life expectancy ≥12 weeks
- 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) and 3 months for males after study drug discontinuation
- Main
Exclusion
- Known CNS metastatic lesions, or evidence of impaired blood-brain barrier as assessed by the investigator
- Have signs or symptoms of active COVID-19 infection or a positive COVID-19 Polymerase Chain Reaction (PCR) test during the screening period
- Impaired renal function by estimated Glomerular Filtration Rate (eGFR) \<30 ml/min as per local assessment
- Laboratory values (hematology and biochemistry) within specified ranges to show appropriate organ function
- Clinically significant cardiac disease,
- Untreated or uncontrolled hypertension
- An underlying medical condition that precludes the ability to take oral medication daily
- Prohibited concomitant therapy
- The patient has had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy other than palliative treatment within 4 weeks prior to screening except for medications with half-lives \<5.5 days
- Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1 in respective Summary of Product Characteristics (SmPC)
- Any bleeding disorder or condition where there is an increased risk of bleeding
- A history of allergic reactions following intake of acetylsalicylic acid or NSAIDs
- A history of gastrointestinal bleeding or perforation
- Active or recurrent gastrointestinal ulcer
- Major surgery within 14 days before enrolment. (Note: trans-urethral resection of bladder tumor is not considered major surgery)
- For female patients of childbearing potential - pregnancy, as confirmed by a serum pregnancy test at screening, or breast-feeding
- 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
- The patient has already participated in the study or been a screening failure
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05390645
Start Date
December 1 2024
End Date
December 1 2025
Last Update
September 26 2024
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden