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Pimasertib once daily

Phase 2

Ovarian Cancer | Small molecule | Oncology |Sanofi|Last Updated: Dec 12, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

Pimasertib once daily · 1 trial · 1 indication

Phase 2 1
NCT01936363Trial of Pimasertib With SAR245409 or Placebo in Ovarian CancerOvarian Cancer
COMPLETED65 Analytics
PHASE2COMPLETED
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Tumor Response
From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months

Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to more than (\<) 10 millimeter (mm). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Secondary Endpoints

Progression-Free Survival
Time from randomization until first observation of progressive disease or death, assessed up to 52 months
Percentage of Participants With Disease Control
Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months
Overall Survival
Time from randomization until death, assessed up to 52 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pimasertib (once daily) plus SAR245409EXPERIMENTAL -
Pimasertib (twice daily) plus SAR245409 placeboEXPERIMENTAL -

Interventions

NameTypeDescription
Pimasertib once dailyDRUGPimasertib 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 placeboDRUGPlacebo matching Pimasertib administered once daily in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
SAR245409 placeboDRUGPlacebo matching SAR245409 administered once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
SAR245409DRUGSAR245409 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 dailyDRUGPimasertib 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * The female participant had a diagnosis of one of the following: a) low-grade serous ovarian or peritoneal carcinoma, or grade 1 serous ovarian or peritoneal carcinoma or well-differentiated serous ovarian or peritoneal carcinoma or b) serous borderline ovarian or peritoneal tu...

Countries:United StatesAustraliaBelgiumCanadaFrancePolandSpain
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about Pimasertib once daily

What is Pimasertib used for in ovarian cancer?

Pimasertib is an investigational small molecule being studied for the treatment of ovarian cancer. It is administered once daily and is currently in Phase 2 clinical development. The drug has been evaluated in a completed clinical trial involving 65 female participants aged 18 years and older.

Who makes Pimasertib?

Pimasertib is being developed by Sanofi, a company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research on this investigational drug for the treatment of ovarian cancer.

What phase is Pimasertib in?

Pimasertib is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 clinical trial for ovarian cancer has been completed, but the drug remains under investigation.

What clinical trials is Pimasertib in?

Pimasertib has been studied in a completed Phase 2 clinical trial identified as NCT01936363. This trial, titled "Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer," enrolled 65 participants and was conducted in the United States, Australia, Belgium, Canada, France, Poland, and Spain.

Is Pimasertib the same as SAR245409?

No, Pimasertib is not the same as SAR245409. In the clinical trial NCT01936363, Pimasertib was studied in combination with SAR245409 or placebo. These are two distinct investigational drugs being evaluated together for the treatment of ovarian cancer.