Status:
WITHDRAWN
Study of CX1106 in Patients With Advanced Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Beijing Konruns Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Chinese Academy of Medical Sciences
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
CX1106 is a novel inhibitor of thymidylate synthase (TS) developed as a potential antitumor agent by virtue of the rate limiting role of TS in the biosynthesis of thymidine. CX1106 differs from other ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed HNSCC (excluding nasopharyngeal carcinoma);
- At least one measurable lesion (spiral CT scan long diameter ≥ 10 mm or enlarged lymph node short diameter ≥ 15 mm by RECIST 1.1);
- Documented disease progression after prior platinum-based systematic therapy; or prior platinum-based adjuvant/neoadjuvant therapy with documented disease progression within 24 weeks after treatment completion;
- Expected overall survival≥ 3 months;
- ECOG PS≤1;
Exclusion
- •Hematologic, renal, and hepatic function as defined below:
- Absolute neutrophil count (ANC) \<1.5×109 /L or platelet \<100×109 /L or hemoglobin \<9 g/dL; Total bilirubin \>1.5×the upper limit of normal range(ULN); Aspartate aminotransferase (AST) and/or Alanine transaminase (ALT) and/or Alkaline phosphatase (ALP) \>1.5×ULN without liver metastases ; AST and/or ALT and/or ALP levels \>5×ULN with liver metastases. Primary hepatocellular carcinoma: Child-Pugh liver is grade C; Serum creatinine\>1.5 ×ULN or creatinine clearance (CL) \< 60 mL/min; International normalized ratio (INR) or activated partial thromboplastin time (aPPT) \>1.5×ULN;
- Patients who has accepted systemic anti-tumor therapy, including chemotherapy, radiotherapy, hormonal therapy , biologics therapy or immunotherapy within 4 weeks;
- Any unresolved Grade ≥2 toxicity by NCI CTCAE 5.0 from previous anticancer therapy excluding skin pigmentation and alopecia;
- Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
- Other kinds of malignancies \[excluding stage IB or lower grade cervical cancer，noninvasive basal cell or squamous cell cancer, breast cancer with complete remission (CR) \> 10 years ,melanoma with CR \>10 years or other malignant tumors with CR \> 5 years\];
- Any of the following gastrointestinal disease:
- Need intravenous nutrition; Received treatment for active peptic ulcer disease in the past 6 months; Active gastrointestinal bleeding unrelated to cancer in the past 3 months; Persistent 3 or 4 grade chronic diarrhea although with treatment;
- Presence of hemorrhage (hemoptysis) , thrombosis，or currently receiving treatment with warfarin, aspirin, low molecular weight heparin (LMWH), or any other anti-platelet drugs(low dose of abovementioned drugs for prophylaxis are allowed);
- Active infections, mental and neurological diseases;
- Prior to enrollment within 12 months , patients who had cardiovascular and cerebrovascular disease, deep vein thrombosis or pulmonary embolism within 6 months; or uncontrolled hypertension,systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg;
- Prior to enrollment within 30 days , patients who had Major surgical procedure, open biopsy, or significant traumatic injury;
- Hepatitis B surface antigen (HBsAg) positive and HBV-DNA≥ 2000 IU / mL;hepatitis C virus (HCV) antibody positive; and cirrhosis;
- Known history of human immunodeficiency virus (HIV) infection;
- Pregnant or lactating women or those who do not take contraceptives, including men;
- Prior to enrollment within 30 days , patients who have participated in other clinical trials of anti-tumor medicine;
- Diseases which would severely endanger the security of patients or influence the completion of this research.
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04093115
Start Date
December 9 2019
End Date
March 31 2020
Last Update
September 3 2020
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