Clinical study of apatinib mesylate in the treatment of platinum resistant recurrent ovarian cancer

• Register: ChiCTR
• Last refreshed on: 14 May 2018
• Main ID: ChiCTR1800016108
• Date of registration: 2018-05-11
• Prospective Registration: No
• Primary sponsor: First Affiliated Hospital of Harbin Medical University
• Public title: Clinical study of apatinib mesylate in the treatment of platinum resistant recurrent ovarian cancer
• Scientific title: Clinical study of apatinib mesylate in the treatment of platinum resistant recurrent ovarian cancer
• Date of first enrolment: 2018-05-10
• Target sample size: Case series:40;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=27326
• Study type: Observational study
• Study design: Non randomized control
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Zhiping Liu
• Affiliation: First Affiliated Hospital of Harbin Medical University

• Name: Zhiping Liu
• Affiliation: First Affiliated Hospital of Harbin Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Women older than eighteen and sign ICF;
2. ECOG 0-2;
3. Estimated survival time=3 mouths;
4. Ovarian epithelial carcinoma diagnosed by pathology or histology;
5. The time of last chemotherapy is more than 4 weeks;
6. The damage caused by other treatments was restored,the interval between nitroso or mitomycin is more than 6 weeks;
7. Other cytotoxic drugs, radiotherapy or surgery were accepted for more than 4 weeks, and the wounds healed completely;
8. The main organs (liver, kidney and heart) function basically normal.
Exclusion criteria: 1. Pregnant or lactating women;
2. High blood pressure and failure to be reduced to normal range by antihypertensive drugs(Systolic pressure > 140 mmHg, diastolic pressure >90mmHg);
3. Variety of factors affecting oral drugs (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
4. Coagulopathy (INR>1.5×ULN APTT>1.5×ULN), with Bleeding tendency;
5. Urinary protein is more than + + and confirmed the 24 hour urinary protein quantitative>1g;
6. Received apatinib or other VEGFR inhibitors, such as bevacizumab, Solafinib, Sunitinib;
7. Metastases of the central nervous system with symptoms;
8. Other cases the researchers judged that could affect the outcome of the clinical study.

Age minimum: 18
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

ovarian cancer

Intervention(s)

Case series:apatinib;

Primary Outcome(s)

ORR;

Secondary Outcome(s)

PFS;OS;

Source(s) of Monetary Support

raise independently

Ethics review

Status: Approved
Approval date:
Contact:

Shiguang Zhao