Relapsed/Refractory Acute Myeloid Leukemia (AML)Phase 1NCT06049667
A Phase 1 Clinical Trail of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies
A Phase 1 study testing NTQ2494 tablet in people with Relapsed/Refractory Acute Myeloid Leukemia (AML), run by Nanjing Chia-tai Tianqing Pharmaceutical at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Acute Myeloid Leukemia (AML)
- What is being tested?
- NTQ2494 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2023to Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years in age, male or female.
- Relapsed/refractory AML patients.
- ECOG performance status score is 0 to 2.
- Life expectancy of at least 3 months.
- Adequate bone marrow and good organ function.
- Ability to understand the purpose and risks of the study and the willingness to sign a written informed consent document.
Who cannot join
- Receiving anticancer therapy including immunotherapy, targeted therapy, endocrine therapy, radiotherapy and chemotherapy within 2 weeks or 5 half-lives (whichever is longer) prior to starting study treatment.
- Receiving any other investigational agents within 4 weeks prior to starting study treatment.
- Having major surgery within 4 weeks prior to starting study treatment, or intended to undergo surgery during the trail.
- AML with any of the following: 1) acute promyelocytic leukemia; 2) AML with blast crisis of chronic myelogenous leukemia; 3) central nervous system leukemia.
- Prior or current other malignancy (except cured noninvasive basal cell or squamous cell skin cancer and/or other cured carcinoma in situ; except for other malignancies that have achieved clinical cure for > 5 years and have not recurred within 5 years).History of severe cardiovascular or cerebrovascular disease.
- Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 7 days prior to starting study treatment.
Show all 17Show fewer
- Receiving (attenuated) live vaccines within 4 weeks prior to starting study treatment and/or planning to receive (attenuated) live vaccines during the trial.
- With unresolved clinically significant non-hematological toxicities from prior AML therapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy and surgery), defined as any grade 2 or higher grade (CTCAE v5.0), alopecia and other events that are tolerable as judged by the investigator.
- Patients who have received previous allogeneic hematopoietic stem cell transplantation; or received autologous hematopoietic stem cell transplantation within 3 months prior to starting study treatment.
- Unable to swallow oral tablets, or other conditions seriously affecting gastrointestinal absorption judged by the investigator.
- Patients with uncontrolled infections unsuitable for the trail judged by the investigator.
- Known infection with hepatitis B, hepatitis C, HIV or Syphilis.
- Known alcohol or drug dependence.
- Patients with mental disorders or poor compliance.
- Patients with a previous history of severe allergy to any drug or food.
- Lactating or pregnant female, and females or males (or partners) who plan to pregnant and do not agree to use adequate contraception for the duration of the trail and up to 3 months after completion of the last study treatment.
- Other reasons judged by the investigator that the patients unsuitable for the trail.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
jianxiang wang
jianxiang wang
About this study
Official title: 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
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.
- Being tested
- NTQ2494 tablet
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTQ2494 tabletDrug
Drug: NTQ2494 tablet Part 1: Dose escalation, single and multiple doses of NTQ2494 with dose modifications based on tolerability criteria.
For each dose level, a single dose of NTQ2494 tablets will be first administered orally, then continuous 28-day treatment will start (per cycle).
Part 2: Dose expansion, recommended doses from Part 1. For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).
| Study group | Role | What they receive |
|---|---|---|
| NTQ2494 | Experimental | For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle). Receives: Drug: NTQ2494 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerance dose (MTD) and dose limiting toxicity (DLT)
MTD is defined as the maximum dose level at which no more than 1 of 3 participants experience a DLT within the days of single dose and the first 28 days of multiple doses in dose escalation part.
Measured: 30 days
Secondary outcomes (24)
Cmax of single dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
AUC0-t of single dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
AUC0-∞ of single dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
Tmax of single dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
t1/2z of single dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
Vz/F of single dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
CLz/F of single dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
λz of single dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
MRT0-t of single dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
Rac of AUC and Cmax of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
DF of AUC and Cmax of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
Css,max of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
Css,min of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
AUCss of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
Cav of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
Tss,max of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
t1/2 of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
Vz/F of first 28 days of multiple doses
、Vz/F、CLss/F、λz of first 28 days of multiple doses.
Measured: At the end of Cycle 1 (each cycle is 28 days)
CLss/F of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
λz of first 28 days of multiple doses
Measured: At the end of Cycle 1 (each cycle is 28 days)
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CRc or PR.
Measured: through study completion, an average of 1 year
Composite response (CRc) rate
CRc rate is defined as the proportion of subjects with confirmed CR or CRi or CRh.
Measured: through study completion, an average of 1 year
Duration of response (DOR)
DOR is defined as the duration from the date of the first documented response of CR or PR to the date of the first documented recurrence or death.
Measured: through study completion, an average of 1 year
Recurrence-free survival (RFS)
RFS is defined as the duration from the date of the first documented response of CRc to the date of the first documented recurrence or death.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start7 Aug 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Nanjing Chia-tai Tianqing PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049667
- Sponsor's protocol ID
- NTQ2494-23101
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06049667
- Acronym / sponsor ID
- NTQ2494-23101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTQ2494 | Experimental | Drug: NTQ2494 tabletFor each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years in age, male or female.
- Relapsed/refractory AML patients.
- ECOG performance status score is 0 to 2.
- Life expectancy of at least 3 months.
- Adequate bone marrow and good organ function.
Key exclusion criteria (17 listed)
- Receiving anticancer therapy including immunotherapy, targeted therapy, endocrine therapy, radiotherapy and chemotherapy within 2 weeks or 5 half-lives (whichever is longer) prior to starting study treatment.
- Receiving any other investigational agents within 4 weeks prior to starting study treatment.
- Having major surgery within 4 weeks prior to starting study treatment, or intended to undergo surgery during the trail.
- AML with any of the following: 1) acute promyelocytic leukemia; 2) AML with blast crisis of chronic myelogenous leukemia; 3) central nervous system leukemia.
- Prior or current other malignancy (except cured noninvasive basal cell or squamous cell skin cancer and/or other cured carcinoma in situ; except for other malignancies that have achieved clinical cure for > 5 years and have not recurred within 5 years).History of severe cardiovascular or cerebrovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTQ2494 tabletDrug: NTQ2494 tablet Part 1: Dose escalation, single and multiple doses of NTQ2494 with dose modifications based on tolerability criteria. For each dose level, a single dose of NTQ2494 tablets will be first administered orally, then continuous 28-day treatment will start (per cycle). Part 2: Dose expansion, recommended doses from Part 1. For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle). | Drug | NTQ2494 |
Primary outcome
Maximum tolerance dose (MTD) and dose limiting toxicity (DLT)
Time frame: 30 days
MTD is defined as the maximum dose level at which no more than 1 of 3 participants experience a DLT within the days of single dose and the first 28 days of multiple doses in dose escalation part.
24 secondary outcomes
Cmax of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
AUC0-t of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
AUC0-∞ of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Tmax of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
t1/2z of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Vz/F of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
CLz/F of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
λz of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
MRT0-t of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Rac of AUC and Cmax of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
DF of AUC and Cmax of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Css,max of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Css,min of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
AUCss of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Cav of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Tss,max of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
t1/2 of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Vz/F of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
CLss/F of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
λz of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Objective response rate (ORR)
Time frame: through study completion, an average of 1 year
Composite response (CRc) rate
Time frame: through study completion, an average of 1 year
Duration of response (DOR)
Time frame: through study completion, an average of 1 year
Recurrence-free survival (RFS)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
Related trials for Relapsed/Refractory Acute Myeloid Leukemia (AML)
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruitingPhase 3
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
RecruitingPhase 1
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
R/R AML, R/R HR-MDS
RecruitingPhase 2
Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
IDH1 Mutation, Relapsed / Refractory AML
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NTQ2494 tablet in people with Relapsed/Refractory Acute Myeloid Leukemia (AML), run by Nanjing Chia-tai Tianqing Pharmaceutical at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu meng Zhou (86-025-85109999, yumeng_zhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerance dose (MTD) and dose limiting toxicity (DLT) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.