Clinical trial NCT01991210 (phase 2, status: terminated)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: dnib0600a, pld
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Reason stopped: 
    the primary objective of pfs did not meet pre-specified criteria.
  
Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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