Clinical Study of Apatinib in the Treatment of Platinum Resistant Recurrent Ovarian Cancer

• Status: Terminated
• Trial end date: 2020-06-14
• Target enrollment: 0
• Participant gender: Female

Summary

For patients with "Platinum-resistant recurrent ovarian cancer" after second-line chemotherapy failure Using apatinib as a single drug Clinical efficacy observation Single study no control

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

Details

• Lead Sponsor: First Affiliated Hospital of Harbin Medical University
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. Female, age ≥18 years, signed informed consent.

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

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

4. Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary. Failure of at least two-line chemotherapy OR platinum resistant ovarian cancer (defined as relapsing within 6 months after a platinum based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing during a platinum based chemotherapy).

5. Criteria for recurrence or metastasis: blood CA125 is more than 2 times the upper limit of normal value, or imaging findings (CT/MRI/PET-CT) show recurrence or metastasis, or ascites cancer cells are positive.

6. Platinum refractory or resistant criteria: relapse or metastasis within 6 months end of platinum based chemotherapy.

7. The interval time to last chemotherapy was more than 4 weeks.

8. The patient received radiotherapy or surgery for more than 4 weeks, and the wound healed completely.

9. 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) (≥ 1.0 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

10. The main organs (liver, kidney and heart) function are basically normal.

Exclusion Criteria:

1. Had prior exposure to apatinib or has known allegies to apatinib.

2. History of other malignant tumors (except those with cured basal cell carcinoma and cervical carcinoma in situ).

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. Patients with QT interval prolongation.

5. Inadequately controlled hypertension.

6. Serious, non-healing wound, active ulcer, bowel obstruction.

7. History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1.

8. Evidence of bleeding diathesis or coagulopathy.

9. Patients with positive urine protein.

10. Major surgical procedure within 28 days prior to Day 1.

11. Symptomatic central nervous system (CNS) metastasis.