Actively Recruiting
A Phase 1 Clinical Trail of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies
Led by Nanjing Chia-tai Tianqing Pharmaceutical · Updated on 2023-09-22
72
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
NTQ2494 tablet, an anti-tumor molecular targeted drug, is an AXL kinase inhibitor. The objectives were to evaluate the safety and tolerability, PK characteristics and preliminary efficacy of NTQ2494 tablets in patients with advanced hematological malignancies.
CONDITIONS
Official Title
A Phase 1 Clinical Trail of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older, male or female
- Diagnosed with relapsed or refractory acute myeloid leukemia (AML)
- ECOG performance status score between 0 and 2
- Life expectancy of at least 3 months
- Adequate bone marrow function and good organ function
- Able to understand the study purpose and risks and willing to sign informed consent
You will not qualify if you...
- Received anticancer therapy (immunotherapy, targeted therapy, endocrine therapy, radiotherapy, chemotherapy) within 2 weeks or 5 half-lives before study treatment
- Received other investigational agents within 4 weeks before study treatment
- Underwent major surgery within 4 weeks before study treatment or plans for surgery during the trial
- AML with acute promyelocytic leukemia, blast crisis of chronic myelogenous leukemia, or central nervous system leukemia
- Prior or current other active malignancy except certain skin cancers or cured cancers with no recurrence for over 5 years
- History of severe cardiovascular or cerebrovascular disease
- Used strong inhibitors or inducers of CYP3A4 or P-gp within 7 days before study treatment
- Received live vaccines within 4 weeks before study or plans to receive during trial
- Unresolved significant non-hematological toxicities from prior AML therapy (grade 2 or higher)
- Previous allogeneic hematopoietic stem cell transplantation or autologous transplantation within 3 months
- Unable to swallow oral tablets or have serious gastrointestinal absorption issues
- Uncontrolled infections deemed unsuitable for the trial
- Known infection with hepatitis B, hepatitis C, HIV, or Syphilis
- Known alcohol or drug dependence
- Mental disorders or poor compliance
- History of severe allergy to any drug or food
- Pregnant or lactating females, or males/females planning pregnancy without agreeing to contraception during and 3 months after the trial
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
Y
Yu meng Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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