Last updated: April 23, 2023
Sponsor: Shandong University
Overall Status: Active - Recruiting
Phase
2
Condition
Ovarian Cysts
Treatment
N/AClinical Study ID
NCT04670978
AB-PRR-EOC
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Recurrent or progressive primary EOC, fallopian tube carcinoma or peritoneal carcinoma (PC) within 6 months of their last previous platinum therapy
- Patients had received at least one prior line of platinum-based chemotherapy
- Patients were required to have one measurable disease for assessment according toRECIST version 1.1 or determined CA125 level according to GCIG
- Eastern Cooperative Oncology Group (ECOG) Performance Status rating of 0-1
- life expectancy ≥3 months
- ≥30 days after surgery, the body has recovered and there is no active infection
- Patients had received at least 1 prior line of platinum-based chemotherapy and wererecurrent or progressed within 6 months after the end of the last platinum-basedregimen
- Must have adequate hematologic and hepatic function
- Subjects of childbearing age must agree to use effective contraception during thetrial period and negative for serum or urine pregnancy test
- Patient provides voluntary written informed consent
Exclusion
Exclusion Criteria:
- Previously received bevacizumab.
- History of other invasive malignancy with the exception of nonmelanoma skin cancer
- Participate in other drug trials
- Blood pressure of >150/100 mmHg on antihypertensive medications
- Previous history of hypertensive crisis or hypertensive encephalopathy
- Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart failure
- The history of myocardial infarction within 6 months
- The history of stroke or transient ischemic attack within 6 months of enrollment
- Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection) orsymptomatic peripheral vascular disease
- Bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Pre-existing peripheral neuropathy of Grade ≥ 2
- Major surgery was performed within 28 days prior to enrollment
- Partial or complete ileus within 3 months prior to study enrollment
- A biopsy or other minor surgery within 7 days prior to study enrollment
- Positive pregnancy test or is lactating
- Abdominal fistula, gastrointestinal perforation or abscess accumulation in theabdominal cavity within 6 months prior to study enrollment
- Severe, nonhealing wound, ulcer, or bone fracture
- Serious intercurrent medical or psychiatric illness, including serious activeinfection
- Uncontrolled systemic infections require antiinfective treatment
- Proteinuria at screening as demonstrated by either
- Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR
- Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria ondipstick urinalysis at baseline should undergo a 24 hour urine collection and mustdemonstrate ≤ 1g of protein in 24 hours to be eligible)
- Known to be allergic, highly sensitive or intolerant to investigational drugs or theirexcipients
Study Design
Total Participants: 96
Study Start date:
March 31, 2021
Estimated Completion Date:
December 31, 2024
Connect with a study center
Qilu Hospital of Shandong University
Jinan, Shandong 250012
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.