Platinum Resistant Ovarian Cancer MedDRA version: 16.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DNIB0600A
Product Code: RO5541081/F01-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DNIB0600A
CAS Number: 1401812-88-1
Current Sponsor code: RO554108
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent form • Age = 18 years • Life expectancy of at least 12 weeks • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 • Histological documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding carcinosarcoma histology) • Availability and willingness to provide an adequate archival sample of tumor (paraffin tissue block or at least 15 unstained slides); if an archival tissue specimen is not available and a new tissue specimen is collected for diagnostic purposes for patient care, then fresh tissue may be submitted • 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 pegylated liposomal doxorubicin (PLD) is appropriate • Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded = 2.0 cm using conventional techniques or = 1.0 cm on spiral computed tomography [CT] scan) per RECIST v1.1 criteria • No more than one prior cytotoxic chemotherapy regimen for the treatment of platinumresistant ovarian cancer and no more than two total regimens (defined as any therapy [approved or investigational] with intent to treat the ovarian cancer) • Absolute neutrophil count = 1500/µL, hemoglobin = 9 g/dL, and platelet count = 100,000/µL • Total bilirubin = 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 ×ULN • Serum creatinine = 2.0 mg/dL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 92 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 pegylated liposomal doxorubicin (PLD) (e.g., Doxil, Caelyx,• Prior treatment with NaPi2b or SCL34A2 targeted therapy • Major surgical procedure within 4 weeks prior to Day 1 • Current Grade > 1 toxicity (except alopecia and anorexia) from prior therapy or Grade > 1 neuropathy from any cause • Left ventricular ejection fraction (LVEF) defined by MUGA/ECHO below the institutional lower limit of normal (LLN) • Evidence of significant, uncontrolled, concomitant disease which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease, history of bronchospasm, or any ongoing requirement for supplemental oxygen)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of DNIB0600A compared with pegylated liposomal doxorubicin (PLD) in patients with PROC as assessed by PFS in patients with NaPi2b-high tumors as well as in the overall patient population.;Secondary Objective: •To evaluate the efficacy of DNIB0600A compared with PLD in patients with PROC as assessed by overall survival (OS) in patients with NaPi2b-high tumors as well as in the overall patient population •To evaluate the anti-tumor activity of DNIB0600A compared with PLD in patients with PROC as assessed by overall response rates and duration of response in patients with NaPi2b-high tumors as well as in the overall patient population •To evaluate the safety and tolerability of DNIB0600A compared with PLD in patients with PROC ;Primary end point(s): Investigator-assessed progression-free survival (PFS) in patients with NaPi2b-high tumors as well as in all patients;Timepoint(s) of evaluation of this end point: Screening and every 8 weeks until discontinuation of the study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Overall survival (OS) in patients with NaPi2b-high tumors as well as in all patients -Investigator-assessed overall response rate (ORR) in patients with NaPi2b-high tumors as well as in all patients -Safety and tolerability;Timepoint(s) of evaluation of this end point: -Throughout the study treatment and every 3 months until death, loss to follow-up, or study closure -Screening and every 8 weeks until discontinuation of the study treatment -Throughout the study treatment until 30 days after the last dose of either DNIB0600A or PLD | — |
Countries
Belgium, Canada, France, Poland, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
Outcome results
None listed