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A Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms

Primary Purpose

Myeloproliferative Neoplasms

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

TQ05105

About this trial

This is an interventional treatment trial for Myeloproliferative Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3; Life expectancy ≥ 3 months.
2. Diagnosed as Primary Myelofibrosis(PMF), Polycythemia Vera(PV), Essential Thrombocythemia(ET), Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post- Essential Thrombocythemia Myelofibrosis (PET-MF).
3. Myelofibrosis at intermediate risk -1 and above according to Dynamic International Prognostic Scoring System(DIPSS); PV or ET were resistant or intolerant to hydroxyurea and/or interferon therapy.
4. Adequate hematology laboratory index. 5.The most prominent part of the spleen ≥ 5cm to the lower edge of the ribs. 6.Bone marrow blasts and peripheral blood blasts <20%. 7. Appropriate liver and kidney functions. 8.The main blood coagulation function is appropriate. 9. Those who have used other MPN treatment drugs before first dose need to stop exceed 2 weeks. Those who have received major surgery before first dose need to exceed 4 weeks.
10.No pregnant or breastfeeding women, and a negative pregnancy test. 11.Understood and signed an informed consent form.

Exclusion Criteria:

1. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. With exception of non-melanoma, skin cancer, and carcinoma in situ.
2. Has participated in other anticancer drug clinical trials within 4 weeks. 3. Has multiple factors affecting oral medication. 4. Has drug abuse history that unable to abstain from or mental disorders. 5. Has active hepatitis B or C, or immunodeficiency. 6. Has immunodeficiency. 7. Has arteriovenous thrombosis events within 4 weeks. 8. Has received long-term and large-dose glucocorticoids or other immunosuppressive drugs within 28 days before signed the informed consent form.
9. Has serious systemic infections. 10. Has uncontrolled cardiovascular disease. 11. Has uncontrolled hypertension. 12. Has serious systemic infections. 13. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sites / Locations

West China Hospital ,Sichuan UniversityRecruiting
Hematology Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TQ05105 Tablet

Arm Description

TQ05105 tablet 5mg administered orally once. Then TQ05105 tablet administered orally, twice daily in 28-day cycle after 3 days of first administration.

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity(DLT)

DLT defined as any of the events occurring during the study related to drugs.

Maximal tolerance dose (MTD)

MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT).

Secondary Outcome Measures

Cmax

Cmax is the maximum plasma concentration of TQ05105 or metabolite(s).

Tmax

To characterize the pharmacokinetics of TQ05105 by assessment of time to reach maximum plasma concentration.

AUC0-t

To characterize the pharmacokinetics of TQ05105 by assessment of area under the plasma concentration time curve from zero to infinity.

Full Information

NCT ID

NCT04339400

First Posted

April 7, 2020

Last Updated

April 7, 2020

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04339400

Brief Title

A Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms

Official Title

A Single-group, Open-label, Multicenter, Phase I Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 20, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

TQ05105 is a JAK2 inhibitors and can be used to treat JAK2 target-related diseases. The activation of the JAK/STAT pathway is related to abnormal proliferation, obstruction of apoptosis, and differentiation disorder of leukemia cells which is caused by genetic abnormalities and viral infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myeloproliferative Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TQ05105 Tablet

Arm Type

Experimental

Arm Description

TQ05105 tablet 5mg administered orally once. Then TQ05105 tablet administered orally, twice daily in 28-day cycle after 3 days of first administration.

Intervention Type

Drug

Intervention Name(s)

TQ05105

Intervention Description

TQ05105 is a JAK2 inhibitor.

Primary Outcome Measure Information:

Title

Dose Limiting Toxicity(DLT)

Description

DLT defined as any of the events occurring during the study related to drugs.

Time Frame

Baseline up to 28 days

Title

Maximal tolerance dose (MTD)

Description

MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT).

Time Frame

Baseline up to 28 days

Secondary Outcome Measure Information:

Title

Cmax

Description

Cmax is the maximum plasma concentration of TQ05105 or metabolite(s).

Time Frame

Hour 0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11, 24 hours post-dose on single dose; Hour 0 of day 1,day 3,day5, day 6 on multiple dose and hour0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11 hours post-dose on multiple dose of day 28.

Title

Tmax

Description

To characterize the pharmacokinetics of TQ05105 by assessment of time to reach maximum plasma concentration.

Time Frame

Title

AUC0-t

Description

To characterize the pharmacokinetics of TQ05105 by assessment of area under the plasma concentration time curve from zero to infinity.

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3; Life expectancy ≥ 3 months. 2. Diagnosed as Primary Myelofibrosis(PMF), Polycythemia Vera(PV), Essential Thrombocythemia(ET), Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post- Essential Thrombocythemia Myelofibrosis (PET-MF). 3. Myelofibrosis at intermediate risk -1 and above according to Dynamic International Prognostic Scoring System(DIPSS); PV or ET were resistant or intolerant to hydroxyurea and/or interferon therapy. 4. Adequate hematology laboratory index. 5.The most prominent part of the spleen ≥ 5cm to the lower edge of the ribs. 6.Bone marrow blasts and peripheral blood blasts <20%. 7. Appropriate liver and kidney functions. 8.The main blood coagulation function is appropriate. 9. Those who have used other MPN treatment drugs before first dose need to stop exceed 2 weeks. Those who have received major surgery before first dose need to exceed 4 weeks. 10.No pregnant or breastfeeding women, and a negative pregnancy test. 11.Understood and signed an informed consent form. Exclusion Criteria: 1. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. With exception of non-melanoma, skin cancer, and carcinoma in situ. 2. Has participated in other anticancer drug clinical trials within 4 weeks. 3. Has multiple factors affecting oral medication. 4. Has drug abuse history that unable to abstain from or mental disorders. 5. Has active hepatitis B or C, or immunodeficiency. 6. Has immunodeficiency. 7. Has arteriovenous thrombosis events within 4 weeks. 8. Has received long-term and large-dose glucocorticoids or other immunosuppressive drugs within 28 days before signed the informed consent form. 9. Has serious systemic infections. 10. Has uncontrolled cardiovascular disease. 11. Has uncontrolled hypertension. 12. Has serious systemic infections. 13. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhijian Xiao, Doctor

Phone

022-23909184

zjxiao@ihcams.ac.cn

Facility Information:

Facility Name

West China Hospital ,Sichuan University

City

Chendu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ling Pan, Doctor

Phone

028-85423046

lingpan20002000@aliyun.com

First Name & Middle Initial & Last Name & Degree

Ling Pan, Doctor

Facility Name

Hematology Hospital, Chinese Academy of Medical Sciences

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhijian Xiao, Doctor

Phone

022-23909184

zjxiao@ihcams.ac.cn

First Name & Middle Initial & Last Name & Degree

Zhijian Xiao, Doctor

12. IPD Sharing Statement

Learn more about this trial

A Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms

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