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MGCD0103

Phase 2

Lymphocytic Leukemia, Chronic | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 1, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

MGCD0103 · 7 trials · 8 indications

Phase 2 2Phase 1 5
NCT00431873A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic LeukemiaLymphocytic Leukemia, Chronic
COMPLETED21 Analytics
NCT00359086Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory LymphomaLymphoma
COMPLETED74 Analytics
PHASE2COMPLETED
A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic Leukemia
Lymphocytic Leukemia, ChronicUnlock trial analytics
PHASE2COMPLETED
Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Response rate
1 year (anticipated)
Maximum tolerated dose in combination with azacitidine
1 year (anticipated)
Clinical response
1 year (anticipated)
Safety and tolerability
1 year (anticipated)
Pharmacokinetics
1 year (anticipated)
Safety and tolerability.
1 year (anticipated)

Secondary Endpoints

Duration of objective response
1 year (anticipated)
Safety profile
1 year (anticipated)
Pharmacodynamics (biomarkers)
1 year (anticipated)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMGCD0103 administered orally three times per week.

Interventions

NameTypeDescription
MGCD0103DRUGMGCD0103 Administered orally three times per week.
GemcitabineDRUGGemcitabine 1000mg/m\<2\> intravenously days 1, 8, 15 of a 28 day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Pathologic confirmation of CLL. * Prior Treatment. There will be no limit to prior therapy. Therapy with fludarabine and Rituxan must have failed (disease progression, intolerance, or not a candidate). * Age 18 years or greater. * ECOG performance status of 0 or 1. * Laborator...

Countries:United StatesCanada
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Frequently asked questions about MGCD0103

What is MGCD0103 used for?

MGCD0103 is an investigational small molecule being studied for use in oncology, specifically for tumors, chronic lymphocytic leukemia, leukemia, lymphoma, and myelodysplastic syndrome. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.

What does MGCD0103 target?

MGCD0103 is a small molecule being developed for oncology indications. The specific molecular target of MGCD0103 has not been disclosed in the available clinical trial information, so its mechanism of action is not detailed here.

Who makes MGCD0103?

MGCD0103 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate this investigational drug for various oncology indications.

What phase is MGCD0103 in?

MGCD0103 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients.

What clinical trials is MGCD0103 in?

MGCD0103 has been studied in four completed Phase 1 clinical trials. These include NCT00323934 for advanced solid tumors or non-Hodgkin's lymphoma, NCT00324129 and NCT00324194 for leukemia or myelodysplastic syndromes, and NCT00372437 for tumors in combination with gemcitabine.

Is MGCD0103 the same as MG-0103?

Yes, MGCD0103 is also referred to as MG-0103 in clinical trial documentation. The trial NCT00372437, which studies MGCD0103 in combination with gemcitabine, uses the name MG-0103 to refer to the same investigational drug.