A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer

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Brief Title

A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer

Official Title

A Multicentre, Open-label, Single-arm Phase II Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (BTC)

Brief Summary

      This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy,
      safety, and pharmacokinetics characteristics of HA121-28 tablets in advanced biliary tract
      cancer (BTC). A total of approximately 30 subjects with advanced BTC will be enrolled. The
      subjects will undergo a 3 weeks-on and 1week-off treatment scheme with HA121-28 tablets 600
      mg orally once daily in the 28-day cycle until disease progression or intolerable toxic
      reaction, whichever occurs first.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

progression-free survival

Secondary Outcome

 objective remission rate

Condition

Biliary Tract Cancer

Intervention

HA121-28 tablets

Study Arms / Comparison Groups

 HA121-28 tablets
Description:  HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

June 22, 2021

Completion Date

December 2024

Primary Completion Date

June 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Be willing to participate in the clinical trial and sign the informed consent;

          -  Histologically/cytologically confirmed unresectable locally advanced or metastatic BTC
             (including cholangiocarcinoma or gallbladder cancer) with failure of or intolerance to
             the prior therapy (including disease progression within 6 months after adjuvant
             chemotherapy) and with at least one measurable lesion based on RECIST 1.1 criteria;

          -  Aged 18 to 75 years (inclusive);

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1;

          -  Routine blood test results must meet the following criteria without blood transfusion
             within 14 days: 1) Hemoglobin (Hb)≥90 g/L; 2) Absolute neutrophil count (ANC)≥1.5 x
             10^9/L; 3) Platelet count (PLT)≥75×10^9/L;

          -  Coagulation test results must meet the following criteria: International Normalized
             Ratio (INR) <1.5 or Activated Partial Thromboplastin Time (APTT) <1.5×ULN;

          -  Other laboratory test results must meet all the following criteria: 1) Total bilirubin
             (TBIL)≤1.5×ULN, Alanine aminotransferase (ALT) and aspartate aminotransferase
             (AST)≤2.5×ULN (TBIL≤3×ULN, ALT and AST≤5×ULN in the subjects with liver metastasis);
             2) Serum creatinine≤1.5×ULN;3) Serum albumin≥28g/L;

          -  Male and female subjects of childbearing potential must agree to take effective
             contraception for the duration of treatment and for 6 months after completion of study
             drug administration; female subjects must have negative results of serum/urine
             pregnancy test within 7 days prior to enrollment and must not be breastfeeding.

        Exclusion Criteria:

          -  Subjects with ampullary carcinoma;

          -  Subjects who had participated in other clinical trials and received the treatment
             within 4 weeks prior to enrolment;

          -  The time interval between the end of the last antitumor treatment and the first
             administration of HA121-28 tablets < 4 weeks (for any antitumor treatment, including
             but not limited to chemotherapy, radiotherapy and targeted therapy), or < 2 weeks (for
             local palliative radiotherapy for pain relief or traditional Chinese medicine with
             approved indications for cancer);

          -  Urine protein≥2+ and urine protein > 1.0g/24h;

          -  History of other malignancies within the past 5 years prior to enrolment, except for
             cured cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder tumor,
             and early esophageal and gastrointestinal cancers that were confined to the mucosal
             layer and resected under endoscopy;

          -  History of any solid-organ or bone-marrow transplantation (except the transplantation
             without immunosuppression such as corneal and hair transplantation);

          -  Unremitted toxic reaction>grade 1 due to any previous treatment at the time of
             enrollment (except for hair loss and pigmentation) which is considered to influence
             the safety evaluation;

          -  ECG meets one of the following criteria: 1) QT/QTc interval≥450ms, congenital long QT
             syndrome (LQTS) or family history of LQTS; 2) any clinically significant abnormalities
             of rhythm, conduction or morphology in the resting ECG requiring therapeutic
             intervention;

          -  Left ventricular ejection fraction (LVEF) <50% in echocardiogram;

          -  Severe concomitant diseases which may have influence on the safety of the subjects or
             the completion of the study based on the investigator' judgement such as uncontrolled
             hypertension (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg after
             treatment);

          -  High risk factors of gastrointestinal diseases such as gastrointestinal perforation
             and abdominal fistula;

          -  Subjects with spinal cord, meningeal or brain metastasis (except for asymptomatic or
             stable brain metastasis within 4 weeks prior to administration);

          -  Subjects with hepatopathy meet one of the following criteria: 1) HBsAg positive and
             HBV DNA >2000 IU/mL(or >1×10^4 copies/mL); 2) HCV antibody positive and HCV RNA
             positive; 3) cirrhosis;

          -  HIV antibody positive;

          -  Subjects have history of surgery within 4 weeks prior to administration or have not
             been recovered from any previous invasive procedure, except for biliary stenting,
             biliary drainage, etc.;

          -  Not suitable for the study in the investigator's opinion.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ruihua Xu, 010-63932012, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04784520

Organization ID

HA122-CSP-002


Responsible Party

Sponsor

Study Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.


Study Sponsor

Ruihua Xu, Principal Investigator, Sun Yat-sen University


Verification Date

March 2021