A Open Label, Dose-Escalation study evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR103 Calcium in patients with relapsed advanced malignancies
Phase 1
- Conditions
- Health Condition 1: C920- Acute myeloblastic leukemia
- Registration Number
- CTRI/2024/04/065493
- Lead Sponsor
- Aurigene Oncology Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Diagnosis of Acute myeloid leukemia (AML) according to the World Health Organization criteria. OR
Myelodysplastic syndrome (MDS) according to the WHO classification.
Provide signed and dated informed consent and agree to comply with all study related activities.
ECOG status of 0 or 1.
Exclusion Criteria
Acute promyelocytic leukemia.
Patients eligible for intensive chemotherapy for AML.
Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall safety profile of the combination AUR 103 Calcium + AZA in patients with AML or intermediate risk or high risk or very high-risk MDS. <br/ ><br>Efficacy assessed by response rates.Timepoint: Baseline, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks,36 weeks,40 weeks, 44 weeks, 48 weeks, 52 weeks and end of study.
- Secondary Outcome Measures
Name Time Method remission according to ELN and IWG criteria.Timepoint: every 3 cycles