Recent Updates
Recently added Catalysts

Eribulin

Phase 1

Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Oct 27, 2015

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Eribulin · 1 trial · 1 indication

Phase 1 1
NCT01585870Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of Sorafenib and Eribulin in CombinationNeoplasms
COMPLETED40 Analytics
PHASE1COMPLETED
Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of Sorafenib and Eribulin in Combination
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with Adverse Events as a Measure of Safety and Tolerability
Up to 30 months
AUC (area under the plasma concentration vs time curve) of BAY43-9006
Up to 9 weeks
Cmax (maximum drug concentration in plasma after single dose administration) of BAY43-9006
Up to 9 weeks
QT time, assessed by QTcF / QTcB (QT interval corrected for heart rate according to Fridericia / Bazett)
Up to 9 weeks

Secondary Endpoints

Clinical benefit and response measured by RESIST (1.1) criteria
Approximately 3-18 weeks depending on tumor response
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sorafenib + EribulinEXPERIMENTAL -

Interventions

NameTypeDescription
Sorafenib (Nexavar, BAY43-9006)DRUGSorafenib (starting dose of 200 mg bid, level 1) administration will begin on Day 11 of Cycle 1, and will be administered twice daily continuously. If the combination is well tolerated, the dose will be escalated in new cohorts to 200 mg AM and 400 mg PM (level 2), then subsequently to 400 mg bid (level 3). If sorafenib starting dose (level 1) is not well tolerated with eribulin, the sorafenib dose will be de-escalated to 200 mg qd (Dose Level -1) in a new cohort.
EribulinDRUGEribulin: 1.4 mg/m2 as an intravenous infusion on Days 1 and 8 of each 21-day cycle.
Unlock Study Design Details

Eligibility Criteria

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

Inclusion Criteria: * Subjects with advanced, metastatic or refractory solid malignancy who are not candidates for standard therapy. For subject with metastatic breast cancer, prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. * Eastern Co...

Countries:FranceGermany
Unlock Eligibility Criteria

Frequently asked questions about Eribulin

What is Eribulin used for?

Eribulin is an investigational small molecule oncology drug being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in Phase 1 clinical development, meaning it is still being evaluated for safety and tolerability in humans and has not yet been approved for any medical use.

Who makes Eribulin?

Eribulin is being developed by Bayer AG, a multinational pharmaceutical company headquartered in Germany. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY. The company is conducting clinical research to evaluate the safety and potential anti-tumor activity of this investigational drug in patients with neoplasms.

What phase is Eribulin in?

Eribulin is currently in Phase 1 clinical development. This early-stage trial is designed to assess the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of the drug when used in combination with another agent. The Phase 1 study has been completed, and Eribulin remains an investigational drug that has not received regulatory approval.

What clinical trials is Eribulin in?

Eribulin has been studied in one completed Phase 1 clinical trial registered as NCT01585870. This trial, titled 'Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of Sorafenib and Eribulin in Combination,' enrolled 40 adult participants with neoplasms at sites in France and Germany. The study was uncontrolled, meaning there was no comparator arm.

How does Eribulin work?

Eribulin is a small molecule that works by targeting and inhibiting microtubule dynamics. It binds to tubulin, a protein that is essential for cell division, and prevents the formation of functional mitotic spindles. This disrupts the process of mitosis, leading to cell cycle arrest and ultimately cell death, particularly in rapidly dividing cancer cells.