A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Array BioPharma
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01649336
First received: July 22, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Drug: MEK162, MEK inhibitor; oral
Drug: Paclitaxel, mitotic inhibitor; intravenous
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the safety profile of the study drug in combination with paclitaxel in terms of adverse events and clinical laboratory tests. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Assess the efficacy of the study drug in combination with paclitaxel in terms of tumor response, duration of response and progression-free survival. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Assess the potential plasma pharmacokinetic (PK) interactions between study drug, metabolites and paclitaxel in terms of plasma concentrations and noncompartmental PK parameters. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Assess possible PK/efficacy and PK/safety correlations. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Assess potential predictive biomarkers of clinical activity for the study drug in combination with paclitaxel. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: July 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEK162 + paclitaxel Drug: MEK162, MEK inhibitor; oral
multiple dose, escalating
Drug: Paclitaxel, mitotic inhibitor; intravenous
multiple dose, single schedule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649336

Contacts
Contact: Array BioPharma Clinical Trial Call Center 303-381-6604

Locations
United States, Arizona
Recruiting
Scottsdale, Arizona, United States
Contact: Deana Garrett, RN    480-860-5000    dgarrett@azpoh.com   
United States, Indiana
Recruiting
Lafayette, Indiana, United States
Contact: Michelle Hamm    765-446-5111 ext 19116    mhamm3@iuhealth.org   
United States, New York
Recruiting
New York, New York, United States
Contact: Rachel Grisham, MD    646-888-4653    grishamr@mskcc.org   
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States
Contact: Alexandria Duncan    615-329-7274    alexandria.duncan@scresearch.net   
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01649336     History of Changes
Other Study ID Numbers: ARRAY-162-112
Study First Received: July 22, 2012
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type
Antimitotic Agents
Paclitaxel
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 20, 2014