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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

Clinicaltrials.gov identifier NCT03924882

Recruitment Status Recruiting

First Posted April 23, 2019

Last update posted April 23, 2019

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:Ovarian Cancer
  • Intervention/Treatment: Drug: Anlotinib
  • Phase: 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
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2022
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
  • Ages Eligible for Study: 18 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

Contacts and Locations
Contacts

Contact: Zhigang Zhang, M.D. 15088621550 zzg2011@zju.edu.cn

Contact: Jianwei Zhou, M.D. 0571-89713634 jianwei-zhou@163.com

Locations

China, Zhejiang
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: Jianwei Zhou, M.D. Second Affiliated Hospital, School of Medicine, Zhejiang University

More Information
  • 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
  • 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: Carcinoma, Ovarian Epithelial Ovarian Neoplasms