Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

The study was designed to evaluate the efficacy and safety of apatinib with albumin-bound paclitaxel in patients with platinum-resistant recurrent ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Apatinib; Paclitaxel

Criteria

Inclusion Criteria:

1. Female, age ≥18 years and ≤70 years, signed informed consent.

2. 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).

3. At least treated with one line of platinum-based chemotherapy.

4. Imaging confirmed diagnosis of progression occurred after the last treatment before enrollment.

5. Histologically or pathologically confirmed diagnosis of ovarian cancer as primary tumor.

6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version.

7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

8. Patients must have a life expectancy of at least 3 months.

9. Patients must have adequate organ function as defined by the following criteria:

10. 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:

• 1.Had prior exposure to apatinib or has known allegies to any of the excipients.

2.Patients with trauma, surgical history, gastrointestinal bleeding, and melena within 1 month prior to treatment.

3.Inadequately controlled hypertension. 4.History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1.

5.Imaging studies suggest that patients with tumors invading important blood vessels.

6.Symptomatic central nervous system (CNS) metastasis. 7.History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.