A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma (HCC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
NanJin Military Eighty-one Hospital, China
Information provided by:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01192971
First received: August 30, 2010
Last updated: September 1, 2010
Last verified: August 2010
  Purpose

This phase II trial will be studying how well Apatinib working in treatment patient with liver cancer.


Condition Intervention Phase
Advanced Hepatocellular Carcinoma
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: Single Arm, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • TTP (Time To Progression) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival safety [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • DCR (Disease control rate [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • ORR (objective response rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • QoL (quality of life) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: July 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 850
Arm 850: Experimental apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patient withdrawal of consent
Drug: Apatinib
apatinib p.o. once daily for 4 weeks
Experimental: B750
B750: apatinib 750 qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Apatinib
apatinib p.o. once daily for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologic confirmed advanced hepatocellular carcinoma
  • Life expectancy of more than 3 months.
  • ECOG performance scale 0 - 2.
  • No cirrhosis with child -pugh score A
  • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan.
  • Adequate hepatic, renal, heart, and hematologic functions (platelets > 90 × 109/L, neutrophil > 1.5 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN).
  • signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • History of any second malignancies within 3 years 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
  • Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
  • Receiving the therapy of thrombolysis or anticoagulation
  • Abuse of alcohol or drugs
  • Less than 4 weeks from the last clinical trial
  • Disability of serious uncontrolled intercurrence infection.
  • Treatment with potent CYP3A4 inhibitors and inducer with 7 and 12 days respectively, prior to study drug administration.
  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: NCT01192971

Contacts
Contact: Hongchen Hu, M.S 13672085298
Contact: Xuemai Pan, B.S 051885475957

Locations
China, Jiangsu
Nanjin Military Eighty -one Hosiptal Recruiting
Nanjin,, Jiangsu, China, 210002
Contact: Xinlei Gong, Dr    025-84453667      
Contact: Liuqin Yang, Dr    025-84453667      
Principal Investigator: Shukui Qin, Dr         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
NanJin Military Eighty-one Hospital, China
Investigators
Principal Investigator: Shukui Qin, Dr Millitary Eighty-one Hosiptal
  More Information

No publications provided

Responsible Party: Dr Qin Shukui, Millatary Eighty-one Hospital
ClinicalTrials.gov Identifier: NCT01192971     History of Changes
Other Study ID Numbers: HENGRUI20100510
Study First Received: August 30, 2010
Last Updated: September 1, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
hcc, apatinib, phase II, cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 14, 2014