Ovarian Cancer Clinical Trial
Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
This is a Phase 1b/2 study of AVB-S6-500 in combination with pegylated liposomal doxorubicin (PLD) or paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer. The phase 1b portion of the study is open label and patients will receive either AVB-S6-500+PLD or AVB-S6-500+ Pac. The Phase 2 portion of the study is randomized, double-blind, placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination with PLD or Pac versus placebo plus PLD or Pac.
While this study was planned as two-part study consisting of a Phase 1b and a Phase 2 portion, the sponsor decided not to proceed with the Phase 2 portion.
The Phase 1b portion of the study was a multicenter, 2-group, open-label design to evaluate the safety and tolerability of AVB-S6-500 combined with PLD or Pac in subjects with platinum-resistant recurrent ovarian cancer. The decision to enroll in the Phase 2 portion of the study was to be driven by the recommendation of a safe and tolerable dose of AVB-S6-500 in combination with each chemotherapy backbone; however, enrollment into the Phase 2 portion was not initiated per Sponsor decision. Given that sufficient data were obtained in the Phase 1b portion AVB-S6-500 + Pac group, the decision was made to pursue a randomized Phase 3 to further study the benefit of this combination versus paclitaxel alone in patients with platinum resistant ovarian cancer.
Age 18 years or older
Histologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer.
Platinum resistant disease, defined as progression within ≤ 6 months from completion of most recent regimen and calculated from the date of the last administered dose of platinum therapy
Must have available archived tumor tissue OR if archived tissue is not available, willing to provide a fresh tumor biopsy
Must have radiologic imaging with a computerized tomography (CT) scan or magnetic resonance imaging (MRI) within 4 weeks of first dose of study drug
Received at least 1 but not more than 3 therapy regimens, not including maintenance or adjuvant therapy
Must have ovarian cancer that is measurable according to RECIST 1.1
ECOG performance status of 0-1
Normal gastrointestinal (GI), bone marrow, liver and kidney function
At least 28 days between termination of prior anti-cancer or hormonal therapy and administration of AVB-S6-500
Primary platinum-refractory disease (defined as progression during the first platinum regimen or within 4 weeks of completion of the first platinum regimen)
Currently being treated with concurrent anti-cancer therapy or any other interventional treatment or trial
Received prior therapy with Pac or PLD in the recurrent setting, depending on physician-chosen chemotherapy for this study
Significant cardiac disease history
Has other prior or concurrent malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
Symptomatic CNS metastasis or metastases
Serious active infection requiring IV antibiotics and/or hospitalization at study entry
Has known previous or current human immune deficiency (HIV) syndrome, hepatitis B, or hepatitis C
Has had paracentesis for ascites within 3 months
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There are 16 Locations for this study
Phoenix Arizona, 85016, United States
Tucson Arizona, 85711, United States
Oakland California, 94611, United States
Roseville California, 95661, United States
San Francisco California, 94115, United States
Santa Clara California, 95051, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Boston Massachusetts, 02214, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 63110, United States
Oklahoma City Oklahoma, 73104, United States
Eugene Oregon, 97401, United States
Austin Texas, 78731, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78240, United States
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