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Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib in the Treatment of Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01531777
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:

RATIONALE:

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable.

PURPOSE:

  1. Studying how well Apatinib works in treating patients.
  2. Finding the efficacy and safety of 500 mg or 750mg Apatinib.
  3. Pharmacokinetics/Pharmacodynamics(PK/PD).
  4. Exploring new outcome measures of antiangiogenic drugs.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Apatinib Drug: apatinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Random, Open, Dose Finding and Pharmacokinetics/Pharmacodynamics(PK/PD) Phase II Study of Apatinib Tablets in the Treatment of Advanced Colorectal Cancer
Study Start Date : April 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Apatinib 500mg
500mg,p.o.,qd
Drug: Apatinib
500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
Experimental: Apatinib 750mg
750mg,p.o.,qd
Drug: apatinib
750 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.



Primary Outcome Measures :
  1. ORR (Objective Response Rate) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. DCR (Disease Control Rate) [ Time Frame: 12 weeks after treatment ]
  2. PFS [ Time Frame: 3 years ]
  3. OS (Overall Survival) [ Time Frame: 3 years ]
  4. QoL (Quality of Life) [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 × 10E+9/L, neutrophil > 1.5 × 10E+9/L, serum creatinine ≤ 1×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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531777


Locations
China, Shanghai
Fudan University cancer hospital
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Fudan University
Investigators
Principal Investigator: Jin Li, MD Fudan University

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01531777     History of Changes
Other Study ID Numbers: APTN-II-CRC
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: February 2012

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Advanced Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases