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Phase 1
18 Years
Open (Enrolling)
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

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Trial Information


Inclusion Criteria:

- Histologically confirmed diagnosis of epithelial ovarian, fallopian tube or primary
peritoneal cancer (measurable or evaluable, nonmeasurable disease) that is
platinum-resistant or refractory. In the judgment of the Investigator, a patient who
is platinum-sensitive but would not benefit from further platinum treatment is also

- Must have had ≥ 1 prior platinum-based chemotherapeutic regimen containing
carboplatin, cisplatin or another organoplatinum compound for management of primary
disease. This initial treatment may have included intraperitoneal (IP) therapy,
consolidation, non-cytotoxic agents or extended therapy administered after surgical
or non-surgical assessment.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.

- Available archival tumor sample (excisional or core biopsy) that can be acquired and
provide consent to biomarker testing of the tumor.

- Additional criteria exist.

Key Exclusion Criteria:

- History or concurrent evidence of central serous retinopathy (CSR), retinal vein
occlusion (RVO) or ophthalmopathy that would be considered a risk factor for CSR/RVO.

- Prior therapy with a MEK inhibitor.

- History of hypersensitivity to taxanes or drug formulations containing Cremophor®.

- History of acute coronary syndromes.

- Uncontrolled or symptomatic brain metastases that are not stable, require steroids,
are potentially life-threatening or that 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 enrollment; patients with adequately resected
basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or
ductal carcinoma in situ may enroll irrespective of the time of diagnosis.

- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis
C, and/or active hepatitis B.

- Treatment with ritonavir at the time of first dose of study treatment.

- Treatment with continuous or intermittent small molecular therapeutics, biologic
therapy or hormonal therapy within 28 days prior to first dose of study treatment.

- Treatment with a cyclical chemotherapy within a period of time that is less than the
cycle length used for that treatment prior to first dose of study treatment.

- Treatment with any other investigational agents within a period of time that is less
than the cycle length used for the treatment or within 28 days (whichever is shorter)
prior to first dose of study treatment.

- Treatment with prior radiotherapy within 21 days prior to first dose of study
treatment; however, if the radiation portal covered ≤ 10% of the bone marrow reserve,
the patient may be enrolled irrespective of the end date of radiotherapy.

- Additional criteria exist.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the recommended Phase 2 dose of study drug in combination with paclitaxel.

Outcome Time Frame:

One year

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

September 2013

Related Keywords:

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



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