Recent Updates
Recently added Catalysts

MKC-1

Phase 2

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

MKC-1 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Mar 2006

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials6
Total Enrollment223

FDA Designations

No designations recorded

MKC-1 clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about MKC-1

What is MKC-1 used for?

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

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 of MKC-1 in oncology indications.

What phase is MKC-1 in?

MKC-1 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug that has not received FDA approval. The completed trials include Phase 1 studies in advanced cancer and hematological malignancies, and Phase 2 studies in pancreatic and ovarian cancer.

What clinical trials is MKC-1 in?

MKC-1 has been studied in four completed clinical trials. These include NCT00408226, a Phase 1 study of MKC-1 with pemetrexed in advanced cancer; NCT00506402, a Phase 1 study in hematologic malignancies; NCT00568646, a Phase 2 study in pancreatic cancer; and NCT00607607, a Phase 2 study in ovarian or endometrial cancer.

Is MKC-1 the same as any other drug?

MKC-1 is not known to have alternative names. It is identified by the code name MKC-1 in clinical trials and is being developed by CASI Pharmaceuticals.