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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01531777
First received: February 7, 2012
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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 efficiency and safety of 500 mg or 750mg Apatinib.
  3. Pharmacokinetics/Pharmacodynamics(PK/PD).
  4. Exploring new outcome measures of antiangiogenic drugs.

Condition Intervention Phase
Colorectal Cancer
Drug: Apatinib
Drug: apatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • ORR (Objective Response Rate) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DCR (Disease Control Rate) [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
  • PFS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • OS (Overall Survival) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • QoL (Quality of Life) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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 × 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531777

Contacts
Contact: JIN LI, MD +86-21-64175590 fudanlijin@163.com

Locations
China, Shanghai
Fudan University cancer hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: JIN LI, MD    +86-21-64175590    fudanlijin@163.com   
Principal Investigator: JIN LI, MD         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Fudan University
Investigators
Principal Investigator: JIN LI, MD Fudan University
  More Information

No publications provided

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01531777     History of Changes
Other Study ID Numbers: APTN-II-CRC
Study First Received: February 7, 2012
Last Updated: February 10, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014