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Study of Dosage Exploration and Pharmacokinetics for HA121-28 Tablets

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ClinicalTrials.gov Identifier: NCT03994484
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE October 10, 2018
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
Maximum Tolerated Dose (MTD) of HA121-28 tablets in Advanced and/or Metastatic Cancer Refractory to Standard Treatment [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any clinically grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v4.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
Antitumor Efficacy of HA121-28 tablets: RECIST criteria version 1.1. [ Time Frame: up to 24 weeks ]
Efficacy evaluation done using RECIST criteria version 1.1.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Dosage Exploration and Pharmacokinetics for HA121-28 Tablets
Official Title  ICMJE Pharmacokinetics of Single and Multiple Doses of HA121-28 Tablets and Exploration of Maximum Tolerated Dose in Patients With Advanced Solid Tumor in PhaseⅠClinical Trial
Brief Summary

There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion).

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of HA121-28 tablets that can be given to patients with advanced cancer. The goal of Phase 2 of this study is to learn if the dose of HA121-28 tablets found in Phase 1 can help to control advanced cancer.

The safety of HA121-28 tablets will be studied in both phases of the study.

Detailed Description

If participants are found to be eligible to take part in this study, they will be assigned to a study group based on when they join this study. Up to 8 groups of up to 20 participants will be enrolled in Phase 1 of the study, and up to 3 groups of up to 24 participants will be enrolled in Phase 2.

If participant is enrolled in Phase 1, the dose of HA121-28 tablets they receive will depend on when they join this study. The first group of participants will receive the lowest dose level of HA121-28 tablets. Each new group will receive a higher dose of HA121-28 tablets than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of HA121-28 tablets is found. If participant is enrolled in Phase 2, they will receive HA121-28 tablets at the low, medium and high doses to select the recommended dose for phase Ⅱ clinical trials.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE
  • Drug: HA121-28 tablets
    Participants will receive oral HA121-28 at a starting dose of 25 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
  • Drug: HA121-28 tablets
    Participants will receive oral HA121-28 at a dose of 50 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
  • Drug: HA121-28 tablets
    Participants will receive oral HA121-28 at a dose of 100 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
  • Drug: HA121-28 tablets
    Participants will receive oral HA121-28 at a dose of 200 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
  • Drug: HA121-28 tablets
    Participants will receive oral HA121-28 at a dose of 300 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
  • Drug: HA121-28 tablets
    Participants will receive oral HA121-28 at a dose of 450 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
  • Drug: HA121-28 tablets
    Participants will receive oral HA121-28 at a dose of 600 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
  • Drug: HA121-28 tablets
    Participants will receive oral HA121-28 at a dose of 800 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
Study Arms  ICMJE Experimental: HA121-28 tables
Participants will receive oral HA121-28 at a starting dose of 25 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
Interventions:
  • Drug: HA121-28 tablets
  • Drug: HA121-28 tablets
  • Drug: HA121-28 tablets
  • Drug: HA121-28 tablets
  • Drug: HA121-28 tablets
  • Drug: HA121-28 tablets
  • Drug: HA121-28 tablets
  • Drug: HA121-28 tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Be willing to participate in the clinical trial and sign the informed consent;
  2. Men and women aged 18 to 75 years;
  3. Histologically/cytologically confirmed advanced/metastatic solid tumor, such as recurrence, unresectable locally advanced/metastatic medullary thyroid carcinoma, non-small cell lung cancer, colorectal cancer, gastric /GEJ adenocarcinoma, and have failed prior standard therapy or for which no standard therapy is durable, that small molecule tyrosine kinase inhibitor therapy is considered a clinically appropriate option (assessed by the researchers);
  4. Subject has not received any anti-cancer therapies including chemotherapy, radiotherapy, targeted treatment and surgery within 4 weeks prior to participation;
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1;
  6. Expected overall survival (Life expectancy)≥ 3 months;
  7. Laboratory test results must meet the following standards:

    Absolute neutrophil count (ANC) ≥1.5 x 10^9/L; Platelet count (PLT) ≥100×10^9/L; Hemoglobin (Hb) ≥90 g/L (no blood transfusion within 14 days); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) (in patients with liver metastasis ≤5.0 x ULN); Total bilirubin ≤ 1.5 x ULN; Serum creatinine≤ 1.5 x ULN;

  8. Male and female subjects of childbearing potential should agree to use suitable method of contraception during the treatment and 6 months after the last dose of study medication; female participants should have negative results of serum/urine pregnancy test within 7 days prior to enrollment and cannot be breastfeeding.

Exclusion Criteria:

  1. Has participated in other clinical trials and received the treatment within 4 weeks prior to enrollment;
  2. Patients who cannot swallow or have chronic diarrhea and intestinal obstruction, which may affect the administration and absorption of the drug;
  3. Subject who meets one of the following criteria:

    • Corrected QT (QTc) ≥470ms in women, ≥450ms in men; or congenital long QT syndrome (LQTS), taking QT prolonging medications, and has a family history of long QT syndrome;
    • Resting ECG result shows clinically significant abnormalities of rhythm, conduction or morphology, requiring therapeutic intervention;
  4. Urinalysis result shows protein in urine ≥ ++ and 24-hour urine protein > 1.0g;
  5. Based on the investigator's assessment, patients with known severe comorbidities which may influence the safety of the patients and the study completion [such as uncontrolled hypertension (systolic pressure ≥140 mmHg or diastolic pressure ≥90 mmHg, despite treated with the optimal medicine), diabetes, etc.];
  6. Patients who have symptoms of metastatic brain/meningeal tumors within 4 weeks of participation;
  7. Ongoing adverse events>grade 1 at the time of participation (except hair loss and pigmentation);
  8. Patients who have undergone major surgery or have not recovered from Invasive operation within 4 weeks prior to initiation of study treatment;
  9. Coagulation disorders (INR >1.5, prothrombin time (PT) > ULN+4s or APTT >1.5ULN): with bleeding diathesis (such as active peptic ulcer) or receiving thrombolytic or anti-coagulant treatment;
  10. Known pulmonary infection/ pneumonitis / interstitial pneumonia who are not suitable for the research;
  11. Known active Hepatitis B or Hepatitis C virus infection;

    • if HBsAg result is positive, additional HBV DNA testing is required (the result is higher than the ULN of the research center);
    • if HCV antibody result is positive, additional HCV RNA testing is required (the result is higher than the ULN of the research center);
  12. Known history of human immunodeficiency virus (HIV), or other acquired/congenital immune deficiency diseases or organ transplantation;
  13. Other anti-tumor therapies are required (including radiotherapy, chemotherapy, immunotherapy, targeted treatment, traditional Chinese medicine, etc.);
  14. Patients with known history of neurological or psychiatric disorders, including epilepsy or dementia;
  15. Not suitable for the treatment assessed by the researchers.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wen Xu 1850063169 xuwen@mail.ecspc.com
Contact: Jia Wang 15210682757 kqkqjia@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994484
Other Study ID Numbers  ICMJE HA121-28/2017/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study Sponsor  ICMJE CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wen Xu Clinical Medicine Department CSPC R&D Business Division
PRS Account CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP