Status:
WITHDRAWN
A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia
Lead Sponsor:
Foresee Pharmaceuticals Co., Ltd.
Conditions:
Fanconi Anemia
Eligibility:
All Genders
3-35 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multi-center, Phase 1/2 study to determine the Optimal Biologic Dose (OBD) and to evaluate the safety, tolerability, PK, and preliminary activity of FP 045 when administered orally in young ...
Detailed Description
Dose escalation will begin with young adult/adolescent patients. The initial two patients enrolled in the study will be \> 15 years of age. These patients must complete the entire 28-day period of tre...
Eligibility Criteria
Inclusion
- male or female aged 3-35
- documented Fanconi anemia by chromosome breakage analysis
- females of child-bearing potential and males required to use highly effective birth control
- mild to moderate bone marrow failure with at least one cytopenia of \> grade 1 severity
Exclusion
- history of any malignancy except focal squamous cell or basal cell carcinoma of the skin or carcinoma in situ of cervix
- has myelodysplastic syndrome or acute leukemia per world health organization (WHO) criteria
- has history of any significant medical conditions
- has aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 5x upper limit of normal (ULN) or calculated creatinine clearance (Clcr) of \< 50 mL/min
- has active Hepatitis B or C
- has an ongoing systemic infection
- requires a strong CYP3A4 inhibitor
- has had major surgery within 30 days
- Active graft versus host disease requiring systemic treatment
- Has a history of bone marrow or stem cell transplant
Key Trial Info
Start Date :
June 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04522375
Start Date
June 30 2023
End Date
December 1 2025
Last Update
March 6 2025
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