A Study in Patients with advanced Ovarian Cancer
- Conditions
- Patients with platinum-resistant or platinum-refractory high-grade serious 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)Therapeutic area: Diseases [C] - Cancer [C04]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)
- Registration Number
- EUCTR2017-004009-42-BE
- Lead Sponsor
- Eli Lilly and Company
- 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.
- 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). Note that the biopsy may be collected prior to the predose Cycle 1 Day 1 pregnancy test and labs.
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 a known serious medical condition (e.g., active infection, increased risk of bleeding events) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol or tolerate the study treatment.
- Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.
- 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 and topical 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