Brief Title
A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Brief Summary
This is a Phase 1 study during which patients with platinum-resistant epithelial ovarian,
fallopian tube or primary peritoneal cancer will receive investigational study drug MEK162
and paclitaxel. Patients will receive increasing doses of study drug in combination with
paclitaxel in order to achieve the highest dose of study drug possible that will not cause
unacceptable side effects. Patients will be followed to see what side effects the combination
causes and what effectiveness the combination has, if any, in treating the cancer.
Approximately 36 patients from the US will be enrolled in this study.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel.
Secondary Outcome
Characterize the safety profile of the study drug in combination with paclitaxel in terms of adverse events and clinical laboratory tests.
Condition
Epithelial Ovarian Cancer
Intervention
MEK162, MEK inhibitor; oral
Study Arms / Comparison Groups
MEK162 + paclitaxel
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
36
Start Date
July 2012
Completion Date
March 2016
Primary Completion Date
March 2016
Eligibility Criteria
Key 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
eligible.
- 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 retinal vein occlusion (RVO) or current risk factors
for 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01649336
Organization ID
ARRAY-162-112
Responsible Party
Sponsor
Study Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
September 2020