Patients with newly diagnosed FIGO stage IIIC - IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas with indication for a carboplatin/paclitaxel chemotherapy framing an interval debulking surgery MedDRA version: 15.0 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: Nintedanib
Product Code: BIBF1120
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Sponsors
ARCAGY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • First diagnosis of histological confirmed (cytology alone excluded) epithelial ovarian cancer, fallopian tube or primary peritoneal cancer. Histology should be obtained by laparoscopy (or by laparotomy), • FIGO-Stages IIIC – IV, • Females, age 18 years or older, • Life expectancy of at least 6 months, • ECOG performance status =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Histological diagnosis of malignant tumour of non-epithelial origin (e.g. germ cell tumour, malignant mixed mullerian tumour, sex cord-stromal tumour) of the ovary, the fallopian tube or peritoneum or borderline tumour of the ovary (tumour of low malignant potential), • Non-healing wound, ulcer (intestinal tract, skin) or bone fracture, • Clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition and/or hydration, • History of major thromboembolic event, • History of at least 2 unprovoked (without a transient or reversible risk factor) events of proximal deep venous thrombosis, • Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy (including deficiency of antithrombin, deficiency of protein C or protein S, Factor V Leiden mutation, Prothrombin G20210A mutation), • Patients with perioperative thrombosis including proximal deep vein thrombosis (DVT) or thrombosis of visceral vessels not associated with pulmonary embolism may be included in the trial if stable therapeutic anticoagulation is documented, • Known inherited or acquired bleeding disorder, • Significant cardiovascular diseases, • Peripheral vascular disease Fontaine stage =3, • Clinically relevant pericardial effusion (e.g. pericardial effusion with echocardiographic or clinical signs of haemodynamic impairment), • History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months, • Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, • Poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy, • Clinical symptoms of brain metastases and/or diagnosis of brain metastases on imaging, • Pre-existing sensory or motor neuropathy CTCAE = 2, except due to trauma, • Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug, • Other malignancy diagnosed within the past 5 years, • Prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy), • Prior radiotherapy to the abdomen or prior radiotherapy to an extra-abdominal target volume that would bear the risk of increased toxicity of chemotherapy, • Hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs, • Serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease, active ulcers (gastrointestinal tract, skin) or a laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study, • Patients with preserved reproductive capacity who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner) during the trial and for at least twelve months after end of active therapy, • Pregnancy or breast feeding, • Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule, • Active alcohol or drug abuse, • Any contraindications for therapy with paclitaxel or carboplatin, e.g. a history of severe hypersensitivity reactions to paclitaxel or platinum-conta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the median Progression-free Survival (PFS) in each study arm (neoadjuvant/adjuvant treatment with or without Nintedanib(Vargatef®).;Secondary Objective: - To evaluate the operative and post-operative complications rate - To evaluate response rate (using RECIST 1.1 and Sugarbaker index) and rate of complete debulking. - To evaluate Biological progression-free interval (PFIbio) by serum CA-125 assessed according to the GCIG criteria - To evaluate best response, overall survival - To assess quality of life - To assess biological activity of BIBF1120 (Vargatef®) and pharmacodynamic markers in blood and in pre/post surgery tumour biopsies. - To describe relations between tumour characteristics (e.g. tumour genotype, gene expression profile etc) and anti-tumour activity.;Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: At least 130 PFS events have been observed (83 in experimental group and 47 in control group) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Response rate - Rate of complete debulking - biological Progression Free Survival - Best response - Overall survival (OS) - Quality of life (QoL) - Safety and tolerability Further exploratory outcome measures on ancillary studies will include: - Translational Sub Studies;Timepoint(s) of evaluation of this end point: OS: 5.5 years appr. | — |
Countries
France
Contacts
Public ContactBéatrice Houy
ARCAGY
Outcome results
None listed