Recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer MedDRA version: 17.0 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: AMG 386
Product Code: AMG 386
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: trebananib
Current Sponsor code: AMG 386
Concentration unit: mg/ml milligram(s)/m
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Female of age 18 years or older • Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer - Subjects with pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, carcinosarcoma, or neuroendocrine histology are excluded - Subjects with borderline ovarian cancer, ie, subjects with low malignant potential tumors, are excluded • Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer • Radiographically evaluable disease per RECIST 1.1 with modifications - There must be radiographically visible tumor - Subjects with only ascites, pericardial, or pleural effusion are excluded • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, neoadjuvant chemotherapy with interval surgery, bevacizumab or extended therapy administered after surgical or non-surgical assessment. - Subjects are allowed to have received, but are not required to have received, 2 additional cytotoxic regimens for management of recurrent or persistent disease • ECOG performance status 0 or 1 • Adequate hematological, renal and hepatic function • Left ventricular ejection fraction (LVEF) = institutional lower limit of normal • Gerenrally well controlled blood pressure , defined as systolic blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range 76
Exclusion criteria
Exclusion criteria: • Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer • Subjects treated with pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy • Subjects with primary platinum-refractory disease - Subjects with recurrence or progression during the first 6 cycles or 12 months from their last platinum-based therapy • History of arterial or venous thromboembolism within 12 months prior to randomization • History of central nervous system metastasis • Clinically significant cardiac disease within 12 months prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS).;Secondary Objective: To evaluate the effect of AMG 386 plus PLD compared to PLD on overall survival (OS).;Primary end point(s): The primary endpoint is progression-free survival (PFS). PFS is defined as the time from the date of randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications, or death from any cause.;Timepoint(s) of evaluation of this end point: When a minimum of 170 PFS events have been observed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Overall survival (OS): time from randomization date to date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date prior to the cutoff date. Subjects known to be alive or dead after the data cutoff date are censored at the data cutoff date. •Objective response rate (ORR) • Duration of response (DOR) • CA-125 response rate per GCIG criteria • Change in CA-125 • Change in tumour burden • Incidence of adverse events and significant laboratory abnormalities • Pharmacokinetics of AMG 386 (eg, Cmax and Cmin) • Incidence of anti-AMG 386 antibody formation • Patient reported HRQOL and ovarian cancer related symptoms using FACT-O • Overall health status using EQ-5D;Timepoint(s) of evaluation of this end point: When a minimum of 170 OS events have been observed | — |
Countries
Australia, Austria, Belgium, Canada, Denmark, European Union, France, Germany, Greece, Hong Kong, Hungary, Italy, Latvia, New Zealand, Poland, Singapore, Slovakia, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed