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Study of CX1106 in Patients With Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093115
Recruitment Status : Withdrawn (The study was terminated voluntarily by the sponsor due to changes in clinical development strategy.)
First Posted : September 17, 2019
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Information provided by (Responsible Party):
Beijing Konruns Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 10, 2019
First Posted Date  ICMJE September 17, 2019
Last Update Posted Date September 3, 2020
Actual Study Start Date  ICMJE December 9, 2019
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2019)
Objective response rate (ORR) [ Time Frame: up to 24 months ]
Defined as the percentage of subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation in Solid Tumor Criteria 1.1 (RECIST 1.1)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2019)
  • Disease control rate (DCR) [ Time Frame: up to 24 months ]
    Defined as the proportion of patients with confirmed complete response, partial response, and stable disease (CR + PR + SD) according to the Response Evaluation in Solid Tumor Criteria 1.1 (RECIST 1.1)
  • Progression-free survival (PFS) [ Time Frame: up to 24 months ]
    Defined as the duration time from the first CX1106 administration to confirmed disease progression (PD) or death of any reason, whichever occurred first
  • Safety profile as assessed by the incidence, duration, and severity of adverse events [ Time Frame: up to 24 months ]
    Incidence, duration, and severity of AEs measured by laboratory assessments and physical findings according to NCI CTCAE 5.0
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 CX1106 in Patients With Advanced Head and Neck Squamous Cell Carcinoma
Official Title  ICMJE A Clinical Trial to Evaluate the Efficacy and Safety of CX1106 in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma After Failure of or Unfit for Platinum-containing Therapy
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 TS inhibitors such as pemetrexed, raltitrexed, CB3717, and fluorouracil in that it does not require active transport for uptake into cells. CX1106 also lacks a glutamate moiety and thus does not require polyglutamation for antitumor activity. More than 1000 patients with various malignancies have been treated with CX1106 to date in previous various clinical trials.

The investigators suggest a study of CX1106 in patients with recurrent or metastatic HNSCC who are resistant or ineligible/intolerant to platinum-based chemotherapy. The aim of current trial is to evaluate the antitumor efficacy and safety profile of CX1106.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Squamous Cell Carcinoma
Intervention  ICMJE Drug: CX1106
administration of CX1106 at 740 mg/m2 as a 24-hour continuous infusion for 5 days (120 h, d1-5), 21 days per cycle, no more than 6 cycles
Study Arms  ICMJE Experimental: CX1106
CX1106 740 mg/m2 as a 24-hour continuous infusion for 5 days every 3 weeks (3 weeks/cycle, 4-6 cycles)
Intervention: Drug: CX1106
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 1, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2019)
30
Actual Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

•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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04093115
Other Study ID Numbers  ICMJE KC-DIAO-004
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
Plan to Share IPD: No
Responsible Party Beijing Konruns Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Beijing Konruns Pharmaceutical Co., Ltd.
Collaborators  ICMJE National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Investigators  ICMJE
Principal Investigator: YuanKai Shi, Doctor Cancer Hospital Chinese Academy of Medical Science
PRS Account Beijing Konruns Pharmaceutical Co., Ltd.
Verification Date September 2020

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