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A Random, Open, Dose Finding and Pharmacokinetics/Pharmacodynamics(PK/PD) Phase II Study of Apatinib Tablets in the Treatment of Advanced Colorectal Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

A Random, Open, Dose Finding and Pharmacokinetics/Pharmacodynamics(PK/PD) Phase II Study of Apatinib Tablets in the Treatment of Advanced Colorectal Cancer


Inclusion Criteria:



- ≥ 18 and ≤ 70 years of age

- Histological confirmed advanced or metastatic colorectal Cancer,at least one
measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5
mm )

- Have failed for ≥ 2 lines of chemotherapy

- Life expectancy of more than 3 months

- ECOG performance scale ≤ 1

- Duration from the last therapy is more than 6 weeks for nitroso or mitomycin More
than 4 weeks for operation, radiotherapy or cytotoxic agents

- Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 109/L,
neutrophil > 1.5 × 109/L, serum creatinine ≤ 1X upper limit of normal(ULN), bilirubin
< 1.25 ULN, and serum transaminase ≤ 2.5× 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:

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

- Pregnant or lactating women

- 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

- Before or at the same time any, second malignancies except cured basal cell carcinoma
of skin and carcinoma in-situ of uterine cervix

- Any factors that influence the usage of oral administration Evidence of CNS
metastasis

- URT: urine protein ≥ ++ and > 1.0 g of 24 h

- PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer
disease) or receiving the therapy of thrombolysis or anticoagulation

- Abuse of drugs

- Certain possibility of gastric or intestine hemorrhage

- Less than 4 weeks from the last clinical trial

- Viral hepatitis type B or type C

- Prior VEGFR inhibitor treatment

- Evidence of significant medical illness that in the investigator's judgment will
substantially increase the risk associated with the subject's participation in and
completion of the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

ORR (Objective Response Rate)

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

JIN LI, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Food and Drug Administration

Study ID:

APTN-II-CRC

NCT ID:

NCT01531777

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Advanced Colorectal Cancer
  • Colorectal Neoplasms

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