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MB07133/m2/day

Phase 1

Hepatocellular Carcinoma | Small molecule | Oncology |Ligand Pharmaceuticals Incorporated|Last Updated: Aug 12, 2011

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

MB07133/m2/day · 1 trial · 1 indication

Phase 1 1
NCT00073736Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular CarcinomaHepatocellular Carcinoma
COMPLETED28 Analytics
PHASE1COMPLETED
Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability
7-day continuous infusion every 28-days as tolerated

To determine the dose-limiting toxicities (DLT) of MB07133; To determine the maximum-tolerated continuous infusion dose (MTD) of MB07133

Secondary Endpoints

Determine effect of MB07133 on tumor size
28 day cycles
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MB07133 Dose Level 1EXPERIMENTAL7-day continuous infusion in 28-day cycles
MB07133 Dose Level 2EXPERIMENTAL7-day continuous infusion in 28-day cycles
MB07133 Dose Level 3EXPERIMENTAL7-day continuous infusion in 28-day cycles
MB07133 Dose Level 4EXPERIMENTAL7-day continuous infusion in 28-day cycles
MB07133 Dose Level 5EXPERIMENTAL7-day continuous infusion in 28-day cycles

Interventions

NameTypeDescription
MB07133 300mg/m2/dayDRUG7-day continuous infusion in 28-day cycles
MB07133 600 mg/m2/dayDRUG7-day continuous infusion in 28-day cycles
MB07133 1200 mg/m2/dayDRUG7-day continuous infusion in 28-day cycles
MB07133 1800 mg/m2/dayDRUG7-day continuous infusion in 28-day cycles
MB07133 2400 mg/m2/dayDRUG7-day continuous infusion in 28-day cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Patients with a diagnosis of local unresectable HCC confirmed by histology using fine needle aspirate (FNA) or liver biopsy. "Local" is defined as disease either restricted to the liver or contiguous with the liver and no identifiable extrahepatic disease. * Patients with Chil...

Countries:United StatesHong KongTaiwan
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Frequently asked questions about MB07133/m2/day

What is MB07133/m2/day used for?

MB07133/m2/day is an investigational small molecule being studied for the treatment of hepatocellular carcinoma, a type of liver cancer. It is administered as an intravenous infusion and is currently in Phase 1 clinical development for this indication.

Who is developing MB07133/m2/day?

MB07133/m2/day is being developed by Ligand Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol LGND. The drug is in Phase 1 clinical development for hepatocellular carcinoma.

What phase is MB07133/m2/day in?

MB07133/m2/day is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its safety and tolerability in patients with unresectable hepatocellular carcinoma.

What clinical trials has MB07133/m2/day been in?

MB07133/m2/day has been studied in one completed Phase 1 clinical trial, identified as NCT00073736. This trial evaluated the safety and tolerability of intravenous infusion of MB07133 in 28 patients with unresectable hepatocellular carcinoma, and was conducted in the United States, Hong Kong, and Taiwan.

Is MB07133/m2/day the same as MB07133?

MB07133/m2/day is a formulation or dosing specification of the drug MB07133. The clinical trial for this asset, NCT00073736, refers to the drug as MB07133, and the drug name MB07133/m2/day indicates the dose per square meter of body surface area per day.