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出境医 / 临床实验 / Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

Study Description
Brief Summary:
The purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Anlotinib Phase 2

Detailed Description:
Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. However, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is important to seek alternative agent that can improve the outcome. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets VEGFR,FGFR,PDGFR,and c-kit,. The preclinical studies suggest anlotinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug anlotinib.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer
Estimated Study Start Date : April 25, 2019
Estimated Primary Completion Date : April 25, 2021
Estimated Study Completion Date : April 25, 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to three years ]
    Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to three years ]
  2. Duration of Response [ Time Frame: Up to three years ]
  3. Frequency and severity of adverse effects as defined by CTCAE version 4.03 [ Time Frame: 30 days after last dose ]

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date  ICMJE April 21, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date April 23, 2019
Estimated Study Start Date  ICMJE April 25, 2019
Estimated Primary Completion Date April 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2019) 		Objective response rate (ORR) [ Time Frame: Up to three years ]
Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2019)
  • Progression-free survival (PFS) [ Time Frame: Up to three years ]
  • Duration of Response [ Time Frame: Up to three years ]
  • Frequency and severity of adverse effects as defined by CTCAE version 4.03 [ Time Frame: 30 days after last dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer
Official Title  ICMJE A Phase II Study of Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer
Brief Summary The purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer
Detailed Description Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. However, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is important to seek alternative agent that can improve the outcome. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets VEGFR,FGFR,PDGFR,and c-kit,. The preclinical studies suggest anlotinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug anlotinib.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 25, 2022
Estimated Primary Completion Date April 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female, age ≥18 years and ≤70 years, signed informed consent.
  2. Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
  3. Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)
  4. At least treated with one line of platinum-based chemotherapy
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version or CA125
  7. Patients must have a life expectancy of at least 3 months.
  8. Patients must have adequate organ function.

Exclusion Criteria:

  1. Had prior exposure to anlotinib or has known allegies to any of the excipients, Inadequately controlled hypertension
  2. History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
  3. History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1
  4. Major surgical procedure within 28 days prior to Day 1, Serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to Day 1
  5. Symptomatic central nervous system (CNS) metastasis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zhigang Zhang, M.D. 15088621550 zzg2011@zju.edu.cn
Contact: Jianwei Zhou, M.D. 0571-89713634 jianwei-zhou@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924882
Other Study ID Numbers  ICMJE AOC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jianwei Zhou, M.D. Second Affiliated Hospital, School of Medicine, Zhejiang University
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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