A Phase II Study of Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

Sponsors

Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Source 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

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.

Overall Status Recruiting
Start Date April 25, 2019
Completion Date April 25, 2022
Primary Completion Date April 25, 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Objective response rate (ORR) Up to three years
Secondary Outcome
Measure Time Frame
Progression-free survival (PFS) Up to three years
Duration of Response Up to three years
Frequency and severity of adverse effects as defined by CTCAE version 4.03 30 days after last dose
Enrollment 30
Condition
Intervention

Intervention type: Drug

Intervention name: Anlotinib

Description: Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Eligibility

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

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jianwei Zhou, M.D. Study Chair Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Contact

Last name: Zhigang Zhang, M.D.

Phone: 15088621550

Email: [email protected]

Location
facility status contact contact_backup The Second Affiliated hospital of Zhejiang University School of Medicine Zhigang Zhang, M.D. 15088621550 [email protected]
Location Countries

China

Verification Date

April 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov