Apatinib in the Treatment of Metastatic Colorectal Cancer

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Apatinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03403452

APAMCRC

Details and patient eligibility

About

This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.

Enrollment

33 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥ 18 and ≤ 80 years of age
Histological confirmed advanced or metastatic colorectal cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral CT
Have failed for ≥ 2 lines of chemotherapy and/or targeted therapy
Life expectancy of more than 3 months
ECOG performance scale 0～1
Duration from the last therapy is more than 4 weeks for operation, radiotherapy or cytotoxic agents
Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 ×10^9/L, neutrophil > 1.5 × 10^9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin < 1.5 ULN, and serum transaminase ≤ 2.0× ULN)
Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article.
Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion criteria

Prior VEGFR inhibitor treatment within 2 weeks
History of other malignancies within 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy
More than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency
Pregnant or lactating women
Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
URT: urine protein ≥ (++)and > 1.0 g of 24 h
PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
Certain possibility of gastric or intestine hemorrhage