A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Array BioPharma
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01849874
First received: May 6, 2013
Last updated: July 3, 2014
Last verified: July 2014

May 6, 2013
July 3, 2014
June 2013
June 2016   (final data collection date for primary outcome measure)
Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased progression-free survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01849874 on ClinicalTrials.gov Archive Site
  • Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased overall survival. [ Time Frame: 6 years post last patient randomized ] [ Designated as safety issue: No ]
  • Obtain additional estimates of the efficacy of study drug vs. physician's choice of selected chemotherapies in terms of objective response rate, duration of response and disease control rate. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Characterize the safety profile of the study drug vs. physician's choice of selected chemotherapies in terms of adverse events and clinical laboratory tests. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Assess the effect on global health status of study drug vs. physician's choice of selected chemotherapies in terms of quality-of-life questionnaires. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Characterize the plasma pharmacokinetics (PK) of study drug in terms of plasma concentration-time profiles and model-based PK parameters. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
Not Provided

The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Approximately 300 patients from North America, Europe and Asia Pacific will be enrolled in this study.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Low-grade Serous Ovarian Cancer
  • Low-grade Serous Fallopian Tube Cancer
  • Low-grade Serous Peritoneal Cancer
  • Drug: MEK162, MEK inhibitor; oral
    multiple dose, single schedule
  • Drug: Physician's choice chemotherapy

    Patients will receive one of the following chemotherapies as determined by the physician:

    • Liposomal doxorubicin, anthracycline antibiotic; intravenous (multiple dose, single schedule)
    • Paclitaxel, mitotic inhibitor; intravenous (multiple dose, single schedule)
    • Topotecan, topoisomerase 1 inhibitor; intravenous (multiple dose, single schedule)
  • Experimental: MEK162
    Intervention: Drug: MEK162, MEK inhibitor; oral
  • Active Comparator: Physician's choice chemotherapy
    Intervention: Drug: Physician's choice chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
June 2016   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • 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. Front-line therapy may include neoadjuvant and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological therapy (e.g. bevacizumab) administered as a single agent is considered a prior systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not considered its own regimen but should be included with the regimen that it follows.
  • 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.
  • Additional criteria exist.

Key Exclusion Criteria:

  • History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
  • 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.
  • Prior randomization into this clinical study.
  • Additional criteria exist.
Female
18 Years and older
No
Contact: Array BioPharma Clinical Trial Call Center 303-381-6604
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   Hungary,   Italy,   Luxembourg,   Netherlands,   Poland,   Spain,   United Kingdom
 
NCT01849874
ARRAY-162-311, 2013-000277-72
Yes
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP