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A Bioequivalence Study of Capecitabine Tablets in Patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer

Phase 1
18 Years
70 Years
Open (Enrolling)
Metastatic Breast Cancer or Metastatic Colorectal Cancer

Thank you

Trial Information

A Bioequivalence Study of Capecitabine Tablets in Patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Area Under Curve (AUC)

Outcome Time Frame:

predose, 0.33,0.67,1,1.5,2,2.5,3,4,5,6,8,hours post-dose

Safety Issue:


Principal Investigator

Wen Ai dong, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

First Affiliated Hospital of Fourth Military Medical University


China: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

July 2013

Related Keywords:

  • Metastatic Breast Cancer or Metastatic Colorectal Cancer
  • Breast Neoplasms
  • Colorectal Neoplasms