Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medical University Innsbruck
With
European Commission
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Ability to understand and willingness to sign and date a written informed consent document
Female patients ≥18 years of age
High-grade serous, high-grade endometrioid, or undifferentiated epithelial ovarian, fallopian tube or primary peritoneal cancer
Patients in part II: High-grade serous, high-grade endometrioid, or undifferentiated epithelial ovarian, fallopian tube or primary peritoneal cancer confirmed by central histopathology through archival formalin-fixed paraffin embedded (FFPE) or fresh-frozen tumour samples.
• Platinum-resistant disease:
primary platinum-resistant disease: progression \> 1 month and ≤ 6 months after completion of primary platinum-based therapy
Patients must have disease that is measurable according to RECIST 1.1 or assessable according to the GCIG (Eastern Cooperative Oncology Group) CA-125 criteria
ECOG performance status of 0-1
Life expectancy of at least 3 months as assessed by the investigator
Adequate function of the bone marrow:
Platelets ≥100 x 109/L
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Haemoglobin ≥ 8.5 g/dl. Patients may receive blood transfusion(s) to maintain haemoglobin values \> 8.5 g/dl.
Adequate organ functions:
Creatinine \< 2 mg/dl (\<177 µmol/L)
Total bilirubin ≤ 1.5 x upper limit of normal
SGOT ( serum glutamate oxaloacetate transaminase)/SGPT (serum glutamate pyruvate transaminase) (AST/ALT) ≤ 3 x upper limit of normal
Urinanalysis 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. Alternatively, proteinuria testing can be performed according to local standards
Negative urine/serum pregnancy test in women of childbearing potential (WOCBP, see section 5). WOCBP who are sexually active, agree to use highly effective means of contraception during the study and for at least 6 months post-study treatment. Allowed are accepted and effective non-hormonal methods of contraception and sexual abstinence or vasectomised partners (\>3 months previously). Vasectomy has to be confirmed by two negative semen analyses.
Availability of archival ovarian cancer tissue for central histopathological review and p53 mutational analysis
You may not be if
Ovarian tumours with low malignant potential (i.e. borderline tumours)
Primary platinum-refractory disease (progression during primary platinum-based chemotherapy)
PRIOR, CURRENT OR PLANNED TREATMENT:
Previous treatment with \> 2 chemotherapy regimens in the platinum-resistant setting (excluding targeted and endocrine therapies).
More than 4 previous lines of chemotherapy.
Major surgery within 2 weeks prior to first dose of ganetespib
PRIOR OR CONCOMITANT CONDITIONS OR PROCEDURES:
Patients with a history of prior malignancies, except, disease-free time-frame of ≥ 3 years prior to randomisation.
Patients with prior in-situ carcinomas, except:
complete removal of the tumour is given
Known history of severe (grade 3 or 4) allergic or hypersensitivity reactions to excipients (e.g., polyethylene glycol \[PEG\] 300 and Polysorbate 80)
History of intolerance or hypersensitivity to paclitaxel and/or adverse events related to paclitaxel that resulted in paclitaxel being permanently discontinued
Peripheral neuropathy of grade \> 2 per NCI CTCAE (Common Toxicity Criteria for Adverse Effects), version 4.03, within 4 weeks prior to randomisation
Clinical symptomatic bowel obstruction at time of screening
Left ventricular ejection fraction defined by MUGA (multigated acquisition)/ECHO below the institutional lower limit of normal
Patients with symptomatic brain metastases
Significant cardiac disease: New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 month; or uncontrolled atrial or ventricular cardiac arrhythmias.
History of prolonged QT syndrome, or family member with prolonged QT syndrome
QTc (corrected QT interval) interval \> 470 msec when 3 consecutive EKG values are averaged
Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (e.g., quinidine, procainamide, disopyramide) or Class III 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)
Any other condition that, in the opinion of the investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study.
Participation in another clinical study with experimental therapy within 28 days before start of treatment.
