Actively Recruiting
SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies
Led by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Updated on 2024-12-17
60
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in the treatment of chemotherapy-induced anemia (CIA) in patients with non-myeloid malignancies
CONDITIONS
Official Title
SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight of 40 kg or more at screening
- Diagnosed with non-myeloid malignancy and planned to receive myelosuppressive chemotherapy for at least 6 weeks
- Chemotherapy-related anemia with hemoglobin 100 g/L or less and a drop of at least 10 g/L after starting chemotherapy
- Ferritin 50 ng/mL or more and transferrin saturation 10% or more at screening
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 6 months or longer as judged by the investigator
- Agree to use acceptable contraception from consent until 90 days after last dose (for males and females of childbearing potential)
- Willing and able to participate and follow study procedures with signed informed consent
You will not qualify if you...
- Receiving chemotherapy expected to cure the tumor
- Receiving hormonal agents, biologics, novel immunosuppressants, or radiation therapy alone for tumor treatment (combination with chemotherapy allowed)
- Received blood transfusion or erythropoiesis-stimulating agents within 4 weeks before first dose
- Abnormal liver or kidney function: ALT or AST over 3 times the normal limit, total bilirubin over 1.5 times normal (exceptions apply), or eGFR under 30 mL/min/1.73 m2
- Heart failure class III or higher, unstable angina, uncontrolled high blood pressure, or significant heart valve disease within 6 months
- Thromboembolic events like deep vein thrombosis or stroke within 6 months
- Anemia caused by other conditions like vitamin deficiency, autoimmune disease, genetic disorders, infection, or active bleeding
- Active systemic infection requiring chronic antibiotics
- Uncontrolled inflammatory or autoimmune diseases
- Need for eye procedures due to diabetic or age-related eye diseases
- Significant gastrointestinal problems affecting drug intake
- Polycystic kidney disease
- Serious or active liver diseases except non-alcoholic fatty liver
- Positive HIV antibody test
- Planned major surgery during the trial
- Myeloid malignancies
- Brain tumors
- Expected use of dapsone during the trial
- Allergy to HIF-PH inhibitors or study drug components
- History of drug or alcohol abuse in past 2 years
- Participation in other clinical trials with investigational products or devices within 8 weeks
- Participation in HIF-PH inhibitor trials within 4 weeks
- Pregnant, breastfeeding, or possibly pregnant
- Use of traditional or herbal medicines for anemia within 2 weeks before first dose
- Any other medical condition that poses safety risks or affects study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
J
Jian Zhou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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