A Study in Patients with advanced Ovarian Cancer
- Conditions
- Patients with platinum-resistant or platinum-refractory high-gradeserous ovarian, primary peritoneal, or fallopian tube cancer who have failed standard of care treatment.MedDRA version: 20.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016182Term: Fallopian tube cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061269Term: Malignant peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-004009-42-ES
- Lead Sponsor
- illy S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 169
- Women who have histologically or cytologically verified high-grade serous ovarian,
primary peritoneal or fallopian tube cancer.
- Cohorts 1 to 3: Have platinum-resistant disease, which is defined as disease
progression within 6 months of last dose of platinum-based chemotherapy.
- Cohort 4: Have primary platinum-refractory disease defined as disease progression
during or within 4 weeks after the last dose of initial line of platinum-based
chemotherapy for ovarian cancer.
- Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy for
high-grade serous ovarian, primary peritoneal, or fallopian tube cancer (including
immunotherapy, targeted therapies, or chemotherapy (systemic or intraperitoneal).
- Cohort 2: Are BRCA negative have received less than 3 prior lines of therapy for
high-grade serous ovarian, primary peritoneal, or fallopian tube cancer (including
immunotherapy, targeted therapies, or chemotherapy (systemic or intraperitoneal).
- Cohort 3: Are BRCA positive and have previously received a PARP inhibitor at any
time following diagnosis.
- Cohort 4: Are BRCA positive or negative; no restriction on number of lines of prior
therapy.
- Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group
(ECOG) scale
- Have adequate organ function,
- Must be able and willing to undergo mandatory tumor biopsy which will be collected following determination of eligibility and before treatment (=28 days before C1D1).
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
- Cohorts 1-3: Have previously received all of the following agents at any time in the
platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and
paclitaxel. It is acceptable to have received 1 or 2 of these agents for platinumresistant
disease.
- Have known central nervous system (CNS) malignancy or metastasis.
- Have at least one of the following:
history of abdominal fistula or gastrointestinal (GI) perforation
intra-abdominal abscess within last 3 months prior to the first dose of study drug
a radiographically confirmed bowel obstruction (including sub-occlusive disease)
within 3 months prior to the first dose of study drug.
- Have a symptomatic human immunodeficiency virus (HIV) infection or symptomatic
activated/reactivated hepatitis A, B, or C (screening is not required).
- Have a serious cardiac condition, such as:
symptomatic congestive heart failure or any uncontrolled cardiac disease
New York Heart Association Class III/IV heart disease
unstable angina pectoris
symptomatic or poorly controlled cardiac arrhythmia
myocardial infarction within the last 3 months
have a QT interval using Fridericia’s correction (QTcF) of >480 msec on more
than one electrocardiogram (ECG) obtained during the baseline (screening) period
family history of long-QT syndrome.
- Have a history of prior radiotherapy to the whole pelvis.
- Have chronic daily treatment with corticosteroids (dose >10 mg/day methylprednisolone
equivalent), excluding inhaled steroids.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method