Study of AVB-S6-500 in Combination With Paclitaxel vs Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
- Interventional
- Recruiting
- NCT04729608
Contact Information
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
This is a Phase 3 study of AVB-S6-500 in combination with paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer. This is a randomized, double-blind, placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination with Pac versus placebo plus Pac.
Gender
Female
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
Inclusion Criteria:
- Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
- Aged 18 years or older
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
- Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).
- Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
- Received at least 1 but not more than 4 prior therapy regimens. Note: maintenance therapy OR hormonal therapies should not be counted as a separate therapy.
- Measurable disease according to RECIST v1.1 criteria
Exclusion Criteria:
- Tumors in the breast or bone
- Untreated central nervous system (CNS) metastases (surgery and/or radiotherapy). Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on >10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
- Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen)
- Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
- Received prior therapy with PAC in the recurrent setting
- Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
- Aged 18 years or older
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
- Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).
- Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
- Received at least 1 but not more than 4 prior therapy regimens. Note: maintenance therapy OR hormonal therapies should not be counted as a separate therapy.
- Measurable disease according to RECIST v1.1 criteria
Exclusion Criteria:
- Tumors in the breast or bone
- Untreated central nervous system (CNS) metastases (surgery and/or radiotherapy). Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on >10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
- Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen)
- Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
- Received prior therapy with PAC in the recurrent setting