A Randomized Double-Blind Phase 3 Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®) in Combination Versus PLD in Participants With Platinum-Resistant Ovarian Cancer
The purpose of this study is to compare progression-free survival (PFS) (based upon investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (EC145+PLD) with that in participants who receive PLD and placebo.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®)
- drug : EC145
- drug : EC20
- drug : placebo
Phase: Phase 3
Ages Eligible For Study:
- Participants must sign an approved informed consent form (ICF). - Participants must be ? 18 years of age. - Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. - Participants must have primary or secondary platinum-resistant ovarian cancer. - Participants must have at least a single (RECIST v1.1-defined) measurable lesion. - For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy (PLD). NOTE: For participants with a history of CNS metastasis, baseline radiological imaging must include an evaluation of the head. - Participants must have had prior debulking surgery. - Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 2 prior systemic cytotoxic regimens. - Participants are allowed to have received, but are not required to have received, one additional non-cytotoxic antitumor agent (eg, biologic or cytostatic) for the management of ovarian cancer. - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. - Participants must have recovered (to baseline/stabilization) from prior cytotoxic therapy-associated acute toxicities. - Participants must have adequate organ function including: 1. Bone Marrow Reserve: 1. Absolute neutrophil count (ANC) ? 1.5x10^9/L prior to treatment. Participants on maintenance doses of granulocyte colony stimulating factor (G-CSF) are eligible. 2. Platelets ? 100x10^9/L 3. Hemoglobin ? 9 g/dL 4. Use of supportive care measures (eg, use of white blood cell [WBC] growth factors, antiemetics, epoetin) should follow the ASCO guidelines as listed at www.asco.org. Participants should receive full supportive care, including transfusion of blood as mandated by clinical need; however, transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of EC145/placebo/PLD is administered are not allowed. 2. Hepatic: Total bilirubin level < 1.5 x ULN and ALT, AST, GGT, and alkaline phosphatase levels < 2.5 x ULN. 3. Renal: Serum creatinine level ? 1.5 x ULN or for participants with serum creatinine levels above 1.5 x ULN, creatinine clearance ? 50 mL/min/1.73m^2 4. Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal.