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MKC-1

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

MKC-1 · 6 trials · 9 indications

Phase 2 3Phase 1 3
NCT00607607A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial CancerOvarian Cancer
COMPLETED44 Analytics
NCT00568646Phase 2 Study of Oral MKC-1 in Patients With Unresectable or Metastatic Pancreatic CancerPancreatic Cancer
COMPLETED33 Analytics
NCT00306631A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1Breast Cancer
COMPLETED65 Analytics
PHASE2COMPLETED
A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer
Ovarian CancerUnlock trial analytics
PHASE2COMPLETED
Phase 2 Study of Oral MKC-1 in Patients With Unresectable or Metastatic Pancreatic Cancer
Pancreatic CancerUnlock trial analytics
PHASE2COMPLETED
A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
Every 4 to 8 weeks
Objective tumor response rate based on tumor measurements according to the RECIST
every 8 weeks
Antitumor activity, based on the objective response rate
every 8 weeks
Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors.
Throughout study participation
Occurrence of treatment emergent adverse events
Throughout study treatment
Occurrence of treatment emergent AEs
throughout study participation

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
Determine evidence of benefit in cancer patients when MKC-1 is administered orally twice a day (bid) continuously by evaluating tumor response and/or tumor marker improvement.
During study participation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALOvarian Cancer Patients
BEXPERIMENTALEndometrial Cancer Patients
1EXPERIMENTAL -

Interventions

NameTypeDescription
MKC-1DRUGcapsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
pemetrexedDRUGstandard dosing of 500 mg/m2 infused every 21 days
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Eligibility Criteria

Age Range18 Years to 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:CanadaUnited States
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about MKC-1

What is MKC-1 used for?

MKC-1 is an investigational small molecule being developed for the treatment of advanced cancer, breast cancer, hematological malignancies, ovarian cancer, and pancreatic cancer. It has been studied in clinical trials for these oncology indications, though it remains in clinical development and is not approved by the FDA.

Who makes MKC-1?

MKC-1 is being developed by CASI Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CASI. The company has sponsored clinical trials evaluating MKC-1 in various cancer types.

What phase is MKC-1 in?

MKC-1 is in Phase 1 clinical development. While some completed trials were Phase 2, the most recent trial listed is Phase 1. It is an investigational drug and has not received FDA approval. All trials for MKC-1 have been completed, with no active trials currently ongoing.

What clinical trials is MKC-1 in?

MKC-1 has been studied in four completed clinical trials. These include NCT00306631 for breast cancer, NCT00408226 for advanced cancer and non-small cell lung cancer, NCT00568646 for pancreatic cancer, and NCT00607607 for ovarian or endometrial cancer. All trials were conducted in the United States or Canada.

Is MKC-1 the same as any other drug?

MKC-1 is not known to have any alternative names. It is a distinct investigational compound developed by CASI Pharmaceuticals. No other names for this drug have been reported in the clinical trial records.