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MKC-1

Phase 2

Ovarian Cancer | Small molecule | Oncology |CASI Pharmaceuticals, Inc.|Last Updated: Jan 20, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00607607A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial CancerPHASE2 COMPLETED 44 — — Jan 1, 2008Jan 1, 2012Jan 20, 20126 Canada
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Study Endpoints
Primary Endpoints
Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
Every 4 to 8 weeks
Secondary Endpoints
Time to progression
Time of progression
Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests.
As reported
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALOvarian Cancer Patients
BEXPERIMENTALEndometrial Cancer Patients
Interventions
NameTypeDescription
MKC-1DRUGcapsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Provide written informed consent (and HIPAA authorization for release of protected health information, as applicable) prior to any study related assessments. 2. Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis, fallopian tube cancers, or e...

Countries:Canada
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Competitive Landscape -Ovarian Cancer 180 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel, Sacituzumab tirumotecan
AstraZeneca PLCAZN19PHASE3Olaparib, Bevacizumab, Durvalumab, Carboplatin+Paclitaxel, AZD5335
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab, Mirvetuximab soravtansine, Carboplatin, Mirvetuximab Soravtansine
GSK plc Sponsored ADRGSK4PHASE3Niraparib, Dostarlimab, Mocertatug rezetecan, Paclitaxel, Pegylated liposomal doxorubicin
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab, BMS-986340, BMS-936558-01, Docetaxel
Pfizer Inc.PFE5PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel /m^2, Relacorilant once daily, Bevacizumab /kg
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib, azenosertib, Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel
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, KFA115, pembrolizumab, Tulmimetostat
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib, BG-68501, Fulvestrant, BGB-43395
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Exelixis, Inc.EXEL2PHASE2Cabozantinib, cabozantinib, atezolizumab
Xencor, Inc.XNCR3PHASE2vudalimab, XmAb541, XmAb808
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