Actively Recruiting
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Preliminary Efficacy 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating NTQ2494 tablet, a drug that targets AXL kinase, in patients with advanced blood cancers, specifically relapsed or refractory acute myeloid leukemia (AML). This phase 1 clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of NTQ2494 in this patient group. The study is sponsored by Nanjing Chia-tai Tianqing Pharmaceutical and focuses on understanding the drug's effects in a controlled setting. The trial involves two parts: an initial dose escalation phase where single and multiple doses of NTQ2494 tablets are given with adjustments based on how well patients tolerate the drug, followed by a dose expansion phase using recommended doses from the first phase. Each treatment cycle lasts 28 days, during which multiple doses of NTQ2494 tablets are taken orally. This approach helps determine the best dosing strategy for patients. Participants will undergo regular evaluations including safety and tolerability assessments, pharmacokinetic measurements such as drug concentration over time, and preliminary efficacy checks. The primary outcome is to identify the maximum tolerated dose and any dose-limiting toxicities within 30 days. Secondary outcomes include detailed pharmacokinetic parameters and response rates tracked over about one year. The overall participation duration varies with continued monitoring for safety and treatment response.
CONDITIONS
Brief 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 or older, male or female
- Diagnosed with relapsed or refractory acute myeloid leukemia (AML)
- ECOG performance status score of 0 to 2
- Life expectancy of at least 3 months
- Adequate bone marrow and good organ function
- Able to understand 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 any other investigational agents within 4 weeks before study treatment
- Had major surgery within 4 weeks before study treatment or planned surgery during trial
- AML with acute promyelocytic leukemia, blast crisis of chronic myelogenous leukemia, or central nervous system leukemia
- Prior or current other malignancy except certain cured skin cancers or cancers cured for more than 5 years
- History of severe cardiovascular or cerebrovascular disease
- Use of strong CYP3A4 or P-gp inhibitors or inducers within 7 days before study treatment
- Received live vaccines within 4 weeks before or planned 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 serious gastrointestinal absorption issues
- Uncontrolled infections unsuitable for 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 persons planning pregnancy without agreed contraception
- Other reasons judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive oral NTQ2494 tablets in repeated 28-day cycles. The first cycle begins with a single dose followed by continuous daily dosing. Dose escalation and modifications are applied based on tolerability.
Visits occur at least at the start and end of each 28-day cycle
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
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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