Back to resultsA Bioequivalence Study of Capecitabine Tablets
Primary Purpose
Metastatic Breast Cancer or Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Capecitabine tablets
XELODA
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer or Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer，without chemotherapy or only adjuvant chemotherapy, and had previously received one or two standard chemotherapy regimens for patients;
- Age: 18-70 years, gender: both，BMI≥17，Eastern Cooperative Oncology Group (ECOG) performance status：0-2，Life expectancy greater than 3 months;
- Patients must have normal bone marrow function, liver and kidney function; adequate organ function in the last 1 week, meeting the following: ANC≥1.5×109/L，PLT≥80×109/L, Total bilirubin≤1.5×the upper limit of normal, ALT,AST≤2.5×the upper limit of normal, creatinine≤1.5×the institutional upper limit of normal.
- Patients who has retreatment could be enrolled at least 4 weeks after the last chemotherapy and radiotherapy.
- Patients must volunteer to participate and sign informed consent form.
Exclusion Criteria:
- Suffering from heart, liver, kidney disease or severe acute and Organ invasion disease;
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
- Pregnant or breast-feeding female
- Only bone metastasis lesions, no other measurable lesions
- Known brain metastasis or history of organ transplantation
- Have long-term systemic steroid therapy
- Serious diseases of vital organs; other malignancies which is not cure
- Use of chemotherapy in the last 4 weeks
- History of drug/alcohol addiction or a positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies
- Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
- Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI CTCAE criteria or known, existing uncontrolled coagulopathy.
- Subjects are thought unsuitable for the study by investigators;
- Inability to comply with protocol or study procedures in the opinion of the investigator;
Sites / Locations
- First Affiliated Hospital of Fourth Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Capecitabine tablets
XELODA
Arm Description
Single oral Capecitabine tablets 2000mg qd
Single oral XELODA 2000mg qd
Outcomes
Primary Outcome Measures
Area Under Curve (AUC)
Secondary Outcome Measures
Full Information
NCT ID
NCT01846650
First Posted
May 1, 2013
Last Updated
September 28, 2013
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01846650
Brief Title
A Bioequivalence Study of Capecitabine Tablets
Official Title
A Bioequivalence Study of Capecitabine Tablets in Patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets (Manufactured by Roche Pharma AG)
Experimental Design： Two-period crossover design
Test drug: Capecitabine tablets Reference drug: XELODA
Sample size：24
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer or Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine tablets
Arm Type
Experimental
Arm Description
Single oral Capecitabine tablets 2000mg qd
Arm Title
XELODA
Arm Type
Active Comparator
Arm Description
Single oral XELODA 2000mg qd
Intervention Type
Drug
Intervention Name(s)
Capecitabine tablets
Intervention Description
Single oral Capecitabine tablets 2000mg qd
Intervention Type
Drug
Intervention Name(s)
XELODA
Intervention Description
Single oral XELODA 2000mg qd
Primary Outcome Measure Information:
Title
Area Under Curve (AUC)
Time Frame
predose, 0.33,0.67，1,1.5,2，2.5，3,4，5,6，8,hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer，without chemotherapy or only adjuvant chemotherapy, and had previously received one or two standard chemotherapy regimens for patients;
Age: 18-70 years, gender: both，BMI≥17，Eastern Cooperative Oncology Group (ECOG) performance status：0-2，Life expectancy greater than 3 months;
Patients must have normal bone marrow function, liver and kidney function; adequate organ function in the last 1 week, meeting the following: ANC≥1.5×109/L，PLT≥80×109/L, Total bilirubin≤1.5×the upper limit of normal, ALT,AST≤2.5×the upper limit of normal, creatinine≤1.5×the institutional upper limit of normal.
Patients who has retreatment could be enrolled at least 4 weeks after the last chemotherapy and radiotherapy.
Patients must volunteer to participate and sign informed consent form.
Exclusion Criteria:
Suffering from heart, liver, kidney disease or severe acute and Organ invasion disease;
Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
Pregnant or breast-feeding female
Only bone metastasis lesions, no other measurable lesions
Known brain metastasis or history of organ transplantation
Have long-term systemic steroid therapy
Serious diseases of vital organs; other malignancies which is not cure
Use of chemotherapy in the last 4 weeks
History of drug/alcohol addiction or a positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies
Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI CTCAE criteria or known, existing uncontrolled coagulopathy.
Subjects are thought unsuitable for the study by investigators;
Inability to comply with protocol or study procedures in the opinion of the investigator;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Ai dong, doctor
Organizational Affiliation
First Affiliated Hospital of Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Fourth Military Medical University
City
Xi an
State/Province
Shanxi
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Bioequivalence Study of Capecitabine Tablets
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