NCT01649336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

3.7 years

First QC Date

July 22, 2012

Last Update Submit

September 9, 2020

Conditions

Epithelial Ovarian CancerFallopian Tube CancerPeritoneal Cancer

Outcome Measures

Primary Outcomes (1)

  • Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel.

    One year

Secondary Outcomes (5)

  • Characterize the safety profile of the study drug in combination with paclitaxel in terms of adverse events and clinical laboratory tests.

    One year

  • Assess the efficacy of the study drug in combination with paclitaxel in terms of tumor response, duration of response and progression-free survival.

    One year

  • Assess the potential plasma pharmacokinetic (PK) interactions between study drug, metabolites and paclitaxel in terms of plasma concentrations and noncompartmental PK parameters.

    One year

  • Assess possible PK/efficacy and PK/safety correlations.

    One year

  • Assess potential predictive biomarkers of clinical activity for the study drug in combination with paclitaxel.

    One year

Study Arms (1)

MEK162 + paclitaxel

EXPERIMENTAL
Drug: MEK162, MEK inhibitor; oralDrug: Paclitaxel, mitotic inhibitor; intravenous

Interventions

MEK162, MEK inhibitor; oralDRUG

multiple dose, escalating

MEK162 + paclitaxel
Paclitaxel, mitotic inhibitor; intravenousDRUG

multiple dose, single schedule

MEK162 + paclitaxel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Scottsdale, Arizona, United States

Location

Pfizer Investigational Site

Lafayette, Indiana, United States

Location

Pfizer Investigational Site

New York, New York, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Interventions

binimetinibPaclitaxelAntimitotic Agents

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesMitosis ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic AgentsTherapeutic Uses

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2012

First Posted

July 25, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations

US(4)