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A Phase II Study for Anlotinib In Combination With Pemetrexed in the treatment of Patients With Platinum Resistant or Refractory Ovarian Cancer

A Phase II Study for Anlotinib In Combination With Pemetrexed in the treatment of Patients With Platinum Resistant or Refractory Ovarian Cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018192
Enrollment
Unknown
Registered
2018-09-04
Start date
2019-01-28
Completion date
Unknown
Last updated
2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

Case series:Anlotinib combined with Pemetrexed

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Histological or pathological confirmed diagnosis of epithelial carcinoma of the ovary, fallopian tube, or peritoneal; 2. Platinum-resistant ovarian cancer (defined as relapsing within 12 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy), at least treated with one line of platinum-based chemotherapy,or at least treated with two different regimens of chemotherapy ; 3. Female aged 18 to 70 years, signed informed consent; 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 6. Patients must have a life expectancy of at least 3 months; 7. Patients must have adequate organ function as defined by the following criteria:White blood cell count = 3 x 10^9/L, Absolute neutrophil count (ANC) (= 1.5 x 10^9/L), Hemoglobin of = 80 g/L, Platelets = 70 x 10^9/L; Total bilirubin = 1 x upper limit of normal (ULN), AST and ALT = 2 x ULN;Serum creatinine = 1 x ULN.

Exclusion criteria

Exclusion criteria: 1. Had prior exposure to anlotinib or has known allegic to any of the excipients; 2. Patients with QT interval prolongation; 3. History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1; 4. History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1; 5. Evidence of bleeding diathesis or coagulopathy; 6. Inadequately controlled hypertension; 7. Major surgical procedure within 28 days prior to Day 1; 8. Symptomatic central nervous system (CNS) metastasis.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Progression-free survival;Duration of Response;

Countries

China

Contacts

Public ContactZhang Yanna

Sun Yat-sen University Cancer Center

zhangyn@sysucc.org.cn+86 020-87343870

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026