ENGOT-ov11/MILO study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician*s Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum

Phase 3

Recruiting

Conditions: Ovarian cancer
10038594

Registration Number: NL-OMON45111

Lead Sponsor: Array BioPharma Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

•Written informed consent
•Diagnosis of LGS carcinoma of the ovary, fallopian tube or primary peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma), confirmed histologically and verified by central pathology review.;•Recurrent or persistent measurable disease that has progressed (defined as radiological and/or clinical progression; an increase in cancer antigen [CA]-125 alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy, surgery) and is not amenable to potentially curative intent surgery, as determined by the patient's treating physician.;•Must have received at least 1 prior platinum-based chemotherapy regimen but have received no more than 3 lines of prior chemotherapy regimens, with no limit to the number of lines of prior hormonal therapy.;•Available archival tumor sample (excisional or core biopsy) for confirmation of LGS carcinoma diagnosis. If adequate archival tumor sample is not available, willingness to consent to tissue biopsy.;•Suitable for treatment with at least one of the physician's choice chemotherapy options (liposomal doxorubicin, paclitaxel or topotecan) as determined by the Investigator.;•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.;•Other protocol-defined inclusion criteria exist.

Exclusion Criteria

•History or current evidence of retinal vein occlusion (RVO), or current risk factors for RVO.;•Prior therapy with a MEK or BRAF inhibitor.;•History of Gilbert's syndrome.;•Impaired cardiovascular function or clinically significant cardiovascular diseases.;•Uncontrolled or symptomatic brain metastases that are not stable or require steroids, are potentially life-threatening or have required radiation within 28 days prior to first dose of study treatment.;•Concomitant malignancies or previous malignancies with less than a 5-year disease-free interval at the time of first dose of study treatment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or ductal carcinoma in situ may be enrolled irrespective of the time of diagnosis.;•Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or active hepatitis C.;•Other protocol-defined exclusion criteria exist.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary:<br /><br>• Progression-free survival as determined by the blinded independent central<br /><br>review (BICR). The local Investigator assessments will be used as supportive<br /><br>analyses</p><br>

Secondary Outcome Measures