Clinical trial NCT03924882: Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer
Official title: A Phase II Study of Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Anlotinib; Ovarian cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to three years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to three years
measure: Duration of Response
timeFrame: Up to three years
measure: Frequency and severity of adverse effects as defined by CTCAE version 4.03
timeFrame: 30 days after last dose
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianwei Zhou, M.D.
role: STUDY_CHAIR
References: