Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
NCT ID: NCT01936363
Last Updated: 2018-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2013-09-30
2017-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pimasertib (once daily) plus SAR245409
Pimasertib once daily
Pimasertib administered as oral capsule at a dose of 60 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
Pimasertib placebo
Placebo matching Pimasertib administered once daily in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
SAR245409
SAR245409 administered as oral capsule at a dose of 70 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
Pimasertib (twice daily) plus SAR245409 placebo
SAR245409 placebo
Placebo matching SAR245409 administered once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
Pimasertib twice daily
Pimasertib administered as oral capsule at a dose of 60 milligram (mg) twice daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pimasertib once daily
Pimasertib administered as oral capsule at a dose of 60 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
Pimasertib placebo
Placebo matching Pimasertib administered once daily in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
SAR245409 placebo
Placebo matching SAR245409 administered once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
SAR245409
SAR245409 administered as oral capsule at a dose of 70 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
Pimasertib twice daily
Pimasertib administered as oral capsule at a dose of 60 milligram (mg) twice daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The participant had at least one prior line of systemic therapy and had a tumor, which was not amenable to potentially curative surgical resection
* The participant had measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* The participant had read and understood the written informed consent form (ICF) and was willing and able to gave informed consent, fully understood the requirements of the trial and was willing to comply with all trial visits and assessments, including completion of patient-reported measures. Consent must be given before any trial related activities
* Women of childbearing potential must had a negative serum pregnancy test at the screening visit
* Women of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and at least 3 months after the last dose of trial medication
Exclusion Criteria
* The participant had been previously treated with a Mitogen-activated protein/extracellular signal-regulated kinase (MEK) inhibitor
* Any anti-cancer therapy or treatment incorporating chemotherapy, immunotherapy, hormonal therapy, or biologic therapy within 28 days of the start of trial treatment or within 5 times the half-life of such treatment, whichever was shorter. Treatment with nitrosoureas or mitomycin C were exceptions to this for which a treatment interval of at least 6 weeks was required
* The participant had not recovered from toxicity due to prior therapy to baseline level or National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) Grade 1 or less (except alopecia). Residual chemotherapy-induced neuropathy grade less than equal to (\<=) 2 was permitted
* The participant had poor organ and marrow function as defined in the protocol
* The participant had creatine phosphokinase (CPK) elevation NCI CTCAE grade greater than equal to (\>=) 2, and/or a previous history of myositis or rhabdomyolysis
* The participant had difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the trial drug. Participants requiring total parenteral nutrition were to be excluded
* The participant had a history of delayed healing/open wounds or diabetic ulcers
* The participant had a history of congestive heart failure, unstable angina, myocardial infarction, cardiac conduction abnormalities including Fridericia corrected QT interval (QTcF) prolongation of \> 480 milliseconds (ms) or a pacemaker, clinically relevant impaired cardiovascular function (New York Heart Association (NYHA) class III/IV) or stroke within 3 months prior to enrollment
* The participant had a history of retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), uveitis or retinal vein occlusion (RVO), or had other relevant abnormalities identified on screening ophthalmologic examination, which might increase the risk of serous retinal detachment (SRD) or RVO
* The participant had a history of uncontrolled intercurrent illness including but not limited to an active infection, hypertension, or uncontrolled diabetes (e.g. glycosylated hemoglobin \>= 8 percent \[%\]) that would limit compliance with treatment requirements
* Any previous malignancy treated with curative intent and the participant had been disease free for less than 5 years prior to randomization, with exception of carcinoma-in-situ of the cervix, squamous carcinoma of the skin, basal cell carcinoma of the skin
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
EMD Serono
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research site
Augusta, Georgia, United States
Research site
Chicago, Illinois, United States
Research site
Indianapolis, Indiana, United States
Research site
Silver Spring, Maryland, United States
Research site
Boston, Massachusetts, United States
Research site
Boston, Massachusetts, United States
Research site
Ann Arbor, Michigan, United States
Research site
Detroit, Michigan, United States
Research site
Kansas City, Missouri, United States
Research site
St Louis, Missouri, United States
Research site
Kalispell, Montana, United States
Research site
New York, New York, United States
Research site
Cincinnati, Ohio, United States
Research site
Columbus, Ohio, United States
Research site
Middletown, Ohio, United States
Research site
Nashville, Tennessee, United States
Research site
Houston, Texas, United States
Research site
Northmead, New South Wales, Australia
Research site
Greenslopes, Queensland, Australia
Research site
Subiaco, Western Australia, Australia
Research site
Kortrijk, , Belgium
Research site
Leuven, , Belgium
Research site
Hamilton, Ontario, Canada
Research site
Toronto, Ontario, Canada
Research site
Montreal, Quebec, Canada
Research site
Montreal, Quebec, Canada
Research site
Québec, , Canada
Research site
Bordeaux, Gironde, France
Research site
Chorzów, , Poland
Research site
Palma Mallorca, Balearic Islands, Spain
Research site
Madrid, , Spain
Research site
Madrid, , Spain
Research site
Seville, , Spain
Research site
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-000902-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMR 200066_012
Identifier Type: -
Identifier Source: org_study_id