A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
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ClinicalTrials.gov Identifier: NCT01849874 |
Recruitment Status :
Active, not recruiting
First Posted : May 9, 2013
Results First Posted : March 30, 2021
Last Update Posted : March 30, 2021
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Low-grade Serous Ovarian Cancer Low-grade Serous Fallopian Tube Cancer Low-grade Serous Peritoneal Cancer |
Interventions |
Drug: MEK162, MEK inhibitor; oral Drug: Physician's choice chemotherapy |
Enrollment | 341 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | MEK162 | Physician's Choice |
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Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug. | Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug. |
Period Title: Overall Study | ||
Started | 201 | 102 |
Treated | 200 | 94 |
Completed | 0 | 0 |
Not Completed | 201 | 102 |
Reason Not Completed | ||
Death | 34 | 16 |
Withdrawal by Subject | 4 | 8 |
Lost to Follow-up | 0 | 1 |
Randomized but Never Treated | 1 | 8 |
Ongoing | 162 | 69 |
Baseline Characteristics
Arm/Group Title | MEK162 | Physician's Choice | Total | |
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Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug. | Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug. | Total of all reporting groups | |
Overall Number of Baseline Participants | 201 | 102 | 303 | |
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The full analysis set included all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 201 participants | 102 participants | 303 participants | |
51.6 (14.5) | 50.2 (13.6) | 51.1 (14.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 201 participants | 102 participants | 303 participants | |
Female |
201 100.0%
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102 100.0%
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303 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01849874 |
Other Study ID Numbers: |
ARRAY-162-311 C4211003 ( Other Identifier: Alias Study Number ) 2013-000277-72 ( EudraCT Number ) |
First Submitted: | May 6, 2013 |
First Posted: | May 9, 2013 |
Results First Submitted: | March 3, 2021 |
Results First Posted: | March 30, 2021 |
Last Update Posted: | March 30, 2021 |