Clareo Health | A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ovarian Cancer (PROC)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months after the most recent treatment with a platinum-containing chemotherapy regimen and for whom PLD is appropriate therapy
No more than 1 prior cytotoxic chemotherapy regimens for the treatment of PROC and not more than 2 total regimens (defined as any therapy \[approved or investigational\] with intent to treat the ovarian cancer)
Adequate hematologic, renal and liver function
Willing and able to perform a patient-reported outcome (PRO) survey (including the possibility of using an electronic PRO device)
For women of childbearing potential, agreement to use 1 highly effective form of contraception as defined by protocol through the course of study treatment and for 6 months after the last dose of study treatment
You may not be if
Primary platinum-refractory disease defined as disease progression during or within 2 months of a first-line, platinum-containing chemotherapy regimen
Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, within 4 weeks prior to Day 1
Palliative radiation within 2 weeks prior to Day 1
Prior anthracycline therapy, including prior treatment with PLD (for example, Doxil®, Caelyx®, or Lipodox®) in any setting (for example, in combination with carboplatin or as a single agent)
Prior treatment with NaPi2b or SCL34A2 targeted therapy
Major surgical procedure within 4 weeks prior to Day 1
Current Grade greater than (\>) 1 toxicity (except alopecia and anorexia) from prior therapy or Grade \>1 neuropathy from any cause
Left ventricular ejection fraction defined by multigated acquisition (MUGA)/echocardiogram below the institutional lower limit of normal
Evidence of significant, uncontrolled, concomitant disease that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or significant pulmonary disease
Known active infection, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (within 4 weeks prior to Cycle 1, Day 1)
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Presence of positive test results for hepatitis B or hepatitis C as detailed in the protocol
Known history of HIV seropositive status
Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, adequately controlled limited basal cell skin cancer, or synchronous primary endometrial cancer or prior primary endometrial cancer
Untreated or active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
Pregnancy or breastfeeding
Known history of NaPi2b deficiency (for example, congenital alveolar microlithiasis or testicular microlithiasis)
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
Metabolic dysfunction, physical examination finding, or clinical laboratory find giving reasonable suspicion of a disease or condition that contraindicated use of an investigational drug or may render the participant at high risk from treatment complications
