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