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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01176669
Other study ID # Fudan BR2010-03
Secondary ID
Status Completed
Phase Phase 2
First received July 20, 2010
Last updated September 8, 2015
Start date June 2010
Est. completion date September 2014

Study information

Verified date September 2015
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The hypothesis of this clinical research study is to discover if the study drug apatinib can shrink or slow the growth of pretreated metastatic triple-negative breast cancer.


Description:

Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR), and its anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The hypothesis of this clinical research study is to discover if the study drug apatinib can shrink or slow the growth of triple-negative breast cancer. The safety of apatinib will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if apatinib is safe and effective in pretreated metastatic triple-negative breast cancer patients.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- = 18 and = 70 years of age.

- ECOG performance status of 0-1.

- Women diagnosed with triple negative breast cancer (breast cancer is estrogen receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor receptor negative (HER2-). HER2- is defined as 0 or 1+ staining on immunohistochemistry or FISH/CISH negative for gene amplification.

- Metastatic breast cancer, confirmed by histological analysis.

- Have failed for at least one chemotherapy regimen, but at most three regimens(including adjuvant and neo-adjuvant setting).

- Duration from the last therapy (chemotherapy, radiotherapy, target therapy and operation) is more than 4 weeks (Duration for nitroso or mitomycin is 6 weeks).

- Have at least one extracranial measurable site of disease according to RECIST 1.1 criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of disease progression since the radiation.

- Life expectancy of more than 3 months.

- If the patients have brain or meninges metastases, the lesions must have been controlled at least 8 weeks.

- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin = 9.0g/dl, neutrophils = 1.5×10^9/L, platelets = 80×10^9/L , ALT = 2.5 x upper limit of normal (ULN), AST = 2.5 x ULN, serum bilirubin = 1.5 x ULN, serum creatine = 1.5 x ULN, creatinine clearance rate = 50ml/min, PT, APTT, TT, Fbg normal).

- Written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice.

Exclusion Criteria:

- Pregnant or lactating women.

- Less than 4 weeks from the last clinical trial.

- Have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: Congestive heart failure: New York Heart Association Class III/IV, Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.

- Any factors that influence the usage of oral administration.

- Receiving the therapy of thrombolysis or anticoagulation.

- Unhealed wound or bone fracture.

- Urine protein =++ and confirmed >1.0 g by the 24h quantity.

- Previous or present history of pulmonary fibrosis,interstitial pneumonia,pneumoconiosis,radiation pneumonitis,drug-related pneumonitis or greatly-impaired pulmonary function.

- Disability of serious uncontrolled intercurrence infection.

- Abuse of alcohol or drugs.

- Have received prior treatment with a VEGFR, PDGFR or s-SRC TKI (Bevacizumab is permitted).

- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Apatinib
Apatinib was administratered at 750 mg/d in Phase IIa. The actual average dose intensity delivered was 525 mg/d due to toxicities. So, in Phase IIb, the starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.

Locations

Country Name City State
China Fudan University Cancer Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Fudan University Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary DCR(Disease control rate) for IIa 8 Weeks Yes
Primary PFS(Progression free survival) for IIb 8 Weeks Yes
Secondary PFS(Progression free survival) for IIa 8 Weeks Yes
Secondary OS (Overall survival) 8 Weeks Yes
Secondary ORR (Objective response rate) 8 Weeks Yes
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability 8 weeks Yes
Secondary QoL (Quality of life) 8 Weeks Yes
Secondary DCR(Disease control rate) for IIb 8 Weeks Yes
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