Epithelial Ovarian CancerPhase 1NCT01649336
A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
A Phase 1 study testing MEK162, MEK inhibitor; oral and Paclitaxel, mitotic inhibitor; intravenous in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- MEK162, MEK inhibitor; oral and Paclitaxel, mitotic inhibitor; intravenous
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2012to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pfizer Investigational Site
Lafayette, Indiana
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Oklahoma City, Oklahoma
Pfizer Investigational Site
Scottsdale, Arizona
About this study
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.
- Being tested
- MEK162, MEK inhibitor; oral, Paclitaxel, mitotic inhibitor; intravenous
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEK162, MEK inhibitor; oralDrug
multiple dose, escalating
Paclitaxel, mitotic inhibitor; intravenousDrug
multiple dose, single schedule
| Study group | Role | What they receive |
|---|---|---|
| MEK162 + paclitaxel | Experimental | Not described Receives: Drug: MEK162, MEK inhibitor; oral; Drug: Paclitaxel, mitotic inhibitor; intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel.
Measured: 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.
Measured: 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.
Measured: One year
Assess the potential plasma pharmacokinetic (PK) interactions between study drug, metabolites and paclitaxel in terms of plasma concentrations and noncompartmental PK parameters.
Measured: One year
Assess possible PK/efficacy and PK/safety correlations.
Measured: One year
Assess potential predictive biomarkers of clinical activity for the study drug in combination with paclitaxel.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649336
- Sponsor's protocol ID
- ARRAY-162-112
- Status last verified
- Sep 2020
- First submitted
- 22 Jul 2012
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT01649336
- Acronym / sponsor ID
- ARRAY-162-112
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEK162 + paclitaxel | Experimental | Drug: MEK162, MEK inhibitor; oral, Drug: Paclitaxel, mitotic inhibitor; intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEK162, MEK inhibitor; oralmultiple dose, escalating | Drug | MEK162 + paclitaxel |
| Paclitaxel, mitotic inhibitor; intravenousmultiple dose, single schedule | Drug | MEK162 + paclitaxel |
Primary outcome
Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel.
Time frame: One year
5 secondary outcomes
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
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
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
Assess possible PK/efficacy and PK/safety correlations.
Time frame: One year
Assess potential predictive biomarkers of clinical activity for the study drug in combination with paclitaxel.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEK162, MEK inhibitor; oral and Paclitaxel, mitotic inhibitor; intravenous in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.