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Trial record 2 of 598 for:    Recruiting, Not yet recruiting, Available Studies | Ovarian cancer

Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03924882
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer


Intervention Details:
  • Drug: Anlotinib
    Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent


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 ]


Information from the National Library of Medicine

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

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

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): NCT03924882


Contacts
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Contact: Zhigang Zhang, M.D. 15088621550 zzg2011@zju.edu.cn
Contact: Jianwei Zhou, M.D. 0571-89713634 jianwei-zhou@163.com

Locations
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China, Zhejiang
The Second Affiliated hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Zhigang Zhang, M.D.    15088621550    zzg2011@zju.edu.cn   
Contact: Jianwei Zhou, M.D.    0571-89713634    jianwei-zhou@163.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Jianwei Zhou, M.D. Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03924882     History of Changes
Other Study ID Numbers: AOC
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Anlotinib; Ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma