Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007750

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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. Patients may be eligible to crossover from physician's choice
chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed
disease progression. Approximately 360 patients from North America, Europe and Australia
will be enrolled in this study.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007750
  •   2015/01/30
  •   2013/05/06
  •   no
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Secondary IDs

  •   2013-000277-72 
  •   NCT01849874  (ClinicalTrials.gov)
  •   ARRAY-162-311  (Array BioPharma)
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Health Condition or Problem studied

  •   Low-grade Serous Ovarian Cancer
  •   Low-grade Serous Fallopian Tube Cancer
  •   Low-grade Serous Peritoneal Cancer
  •   C56 -  Malignant neoplasm of ovary
  •   C57.0 -  Malignant neoplasm: Fallopian tube
  •   C48.2 -  Malignant neoplasm: Peritoneum, unspecified
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Interventions/Observational Groups

  •   Drug: MEK162, MEK inhibitor; oral
  •   Drug: Physician's choice chemotherapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased progression-free survival.; time frame: 3 years

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Secondary Outcome

- Obtain additional estimates of the efficacy of study drug vs. physician's choice of selected chemotherapies in terms of overall survival, objective response rate, duration of response and disease control rate.; time frame: 6 years
- 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
- 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
- Characterize the plasma pharmacokinetics (PK) of study drug in terms of plasma concentration-time profiles and model-based PK parameters.; time frame: 3 years

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Hungary
  •   Ireland
  •   Italy
  •   Luxembourg
  •   Netherlands
  •   Norway
  •   Poland
  •   Spain
  •   Sweden
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2013/06/30
  •   360
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional 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

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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.

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Addresses

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    • Array BioPharma
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    • 303-381-6604
    • Array BioPharma 
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    • 303-381-6604
    • Array BioPharma 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2017/05/16
* This entry means the parameter is not applicable or has not been set.