EUCTR2017-004058-40-ATActive, not recruitingPhase 1
A multicentre, open-label, three-arm randomised Phase II trial assessing the safety and efficacy of the HSP90 inhibitor Ganetespib in combination with Carboplatin followed by maintenance treatment with Niraparib versus Ganetespib plus Carboplatin followed by Ganetespib and Niraparib versus Carboplatin in combination with standard chemotherapy followed by Niraparib maintenance treatment in platinum-sensitive ovarian cancer patients - EUDARIO: European Trial on enhanced DNA Repair Inhibition in Ovarian Cancer
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Ability to understand and willingness to sign and date a written informed consent document
- •Female patients = 18 year of age
- •High-grade serous, high grade endometrioid, undifferentiated epithelial ovarian, or carcinosarcoma, fallopian tube or primary peritoneal cancer
- •Platinum-sensitive relapse > 6 months after previous platinum-based treatment (calculated from the first day of the last cycle of the last platinum based chemotherapy until the date of progression confirmed according to RECIST 1.1 on imaging)
- •No limits in number of prior treatment lines
- •Measurable or evaluable disease according to RECIST 1.1
- •ECOG performance status 0-1
- •Adequate functions of the bone marrow:
- •oPlatelets = 100 x 109/L
- •oAbsolute neutrophil count (ANC) = 1.5 x 109/L
- •Adequate function of the organs:
- •oCreatinine < 2 mg/dl (<177 µmol/L)
- •oTotal bilirubin = 1.5 x upper limit of normal (= 2.0 in patients with known Gilberts syndrome) OR direct bilirubin = 1 x ULN
- •oSGOT/SGPT (AST/ALT) = 2.5 x upper limit of normal unless liver metastases are present, in which case they must be = 5 x ULN
- •oUrinanalysis or urine dipstick for proteinuria less than 2+. Patients with = 2+ on dipstick should undergo 24-hour urine collection and must demonstrate < 1 g of protein/24 hours; except the proteinuria is clearly related to a catheter in the urinary system.
- •Adequate coagulation parameter: aPTT = 1.5 x ULN (patients on heparin treatment must have an aPTT between 1.5-2.5 x ULN), or INR = 1.5. (In patients receiving anticoagulants (such as warfarin) INR must be between 2.0 and 3.0 in two consecutive measurements 1-4 days apart).
- •Participant receiving corticosteroids (dose < 10 mg/day methylprednisolone equivalent), including inhaled steroids, may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.
- •Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
- •Female participant has a negative serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of nonchildbearing potential. Nonchildbearing potential is defined as follows (by other than medical reasons):
- •o= 45 years of age and has not had menses for >1 year
- •oPatients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating
- •hormone value in the postmenopausal range upon screening evaluation
- •oPost-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with
- •medical records of the actual procedure or confirmed by imaging. Tubal ligation must be confirmed with medical records of the actual procedure,
- •otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days
- •after the last dose of study treatment. See below for a list of acceptable birth control methods. Information must be captured appropriately within
- •the site’s source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
- •oBirth Control: Participants of childbearing potential who are sexually active and their partners must agree to the use of a highl
Exclusion Criteria
- •Ovarian tumours with low malignant potential (i.e. borderline tumours)
- •Any prior radiotherapy to the pelvis or abdomen, or any radiotherapy encompassing > 20 % of the bone marrow within 2 weeks, or any radiotherapy within 1 week prior to Day 1 of protocol therapy.
- •Surgery (including open biopsy and traumatic injury) within 4 weeks prior to first dose of Ganetespib, or anticipation of the need for major surgery during study treatment
- •Minor surgical procedures, within 24 hours prior to the first study treatment
- •Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- •Any serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
- •Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (> 325 mg/day).
- •Patients with a history of diagnosis, detection or treatment of any prior malignancies = 2 years prior to initiating protocol therapy, except: basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated.
- •Clinically significant gastro-intestinal (GI) tract abnormalities that may increase the risk for GI bleeding and / or perforation including but not limited to: active peptic ulcer disease, known intraluminal metastatic lesion/s with risk of bleeding; inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), history of bowel obstruction within 1 year prior to first study treatment (excluding postoperative, i.e. within 4 weeks post surgery), other GI condition with increased risk of perforation such as recurrence deeply infiltrating into the muscularis or mucosa of the rectosigmoid or the mucosa of the bladder, or history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
- •Non-healing wound or non-healing bone fracture
- •Patients with symptomatic brain or leptomeningeal metastases (patients who are asyptomatic since treatment of brain or leptomeningeal metastases, eg after irradiation, are eligible)
- •Left ventricular ejection fraction (LVEF) defined by ECHO below the institutional lower limit of normal
- •Cerebrovascular accident (CVA)/ stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within = 6 months prior to first study treatment.
- •Significant cardiac disease: New Yourk Heart Assiciation (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary atrial or ventricular cardiac arrhythmias
- •History of prolonged QT syndrome, or family member with prolonged QT syndrome
- •QTc interval > 470 msec when 3 consecutive ECG values are averaged
- •Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (e.g. sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted
- •Second- or third-degree atrioventricular (AV) block, except: treated with a permanent pacemaker
- •Complete left bundle branch block (LBBB)
- •History of evidence of haemorrhagic disorders, patients with active bleeding or pathologic conditions that carry high risk of bleeding, s
Investigators
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