AVB500-OC-004 - AVB-S6-500 in Recurrent Ovarian Cancer
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB S6 500 in Combination with Paclitaxel in Patients with Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)
IRAS ID
1004268
Contact name
Jody Gould
Contact email
Sponsor organisation
ARAVIVE INCORPORATED
Eudract number
2021-000293-28
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out if AVB S6 500 is effective, safe, and tolerated when administered to women suffering from recurrent ovarian cancer that came back after platinum chemotherapy
The drug going to be tested is AVB-S6-500 that should prevent cancer to spread in other parts of the body. Currently it is not possible to say whether the treatment will be of beneficial in treating ovarian cancer or relieving symptoms
The study is randomized, double blind, and patients will receive either AVB-S6-500+paclitaxel (a standard treatment) or placebo+paclitaxel. Neither the investigator nor the patient will know which treatment arm the patients is assigned to, but if necessary for safety reasons, the study doctor can find out which treatment the patient is receiving.
AVB-S6-500 is administered at Days 1 and 15 while Paclitaxel is given on days 1, 8 and 15 of each 28-days cycle. They will be given by infusion which last approximately 1 hour and will be given prior to paclitaxel if scheduled on that day. Patients will have 28-days cycles until disease progresses. After that, patients will be followed up for survival until 5 years after the end of treatment. Study duration is variable and depends on how long the patient has benefit from the therapy and on the duration of the follow-up period. It can last even 7 years.
During the study visits measurement of vital signs, physical examination, electrocardiogram, blood and urine samples collection are performed. If no previous tumor biopsy is available a fresh screening biopsy will be taken. Optional biopsies may also be taken.
The side effects that were seen most commonly when patients were treated with AVB S6 500 in combination with chemotherapy are: tiredness, anemia, nausea and infusion reactions.
Since the study drug is investigational, there may be other risks that are unknown and there may be risks to a pregnancy. Then, all subjects of childbearing potential should have pregnancy tests during the study.REC name
London - South East Research Ethics Committee
REC reference
21/LO/0842
Date of REC Opinion
21 Dec 2021
REC opinion
Further Information Favourable Opinion