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epothilone b

Phase 2

Breast Neoplasms | Small molecule | Oncology |Novartis AG|Trials Updated: Dec 17, 2020

epothilone b development status

Highest phase Phase 2
Registered trials 8 across 1 sponsor since May 2002

epothilone b target and mechanism

Molecular targetTUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, TUBA1A
Target classStabiliser
ModalitySmall molecule

Also known as EPO906

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials8
Total Enrollment1,203

FDA Designations

No designations recorded

epothilone b clinical trials

epothilone b · 8 trials · 12 indications

Phase 3 1Phase 2 6Phase 1 1
NCT00262990Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal CancerOvarian Cancer
COMPLETED829 Analytics
PHASE3COMPLETED
Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
every 8 weeks
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Tumor response (complete response (CR), partial response (PR), stable disease (SD))
at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)

Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.

Tumor response rate
Every 2 cycles

tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).

To identifymaximum tolerated dose (MTD)
During cycle 1 and 2 (approx 6 to 8 wks)

Secondary Endpoints

To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)
End of study
To determine the progression-free survival (PFS) of patients treated with patupilone
end of study
To determine the time to disease progression (TTP) of patients treated with patupilone
end of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PatupiloneEXPERIMENTAL -
doxorubicinACTIVE_COMPARATOR -
EPO906EXPERIMENTAL -
BolusEXPERIMENTAL20 min bolus infusion
CIV-1dEXPERIMENTAL1 day continuous infusion
CIV-5dEXPERIMENTAL5 day continuous infusion

Interventions

NameTypeDescription
EPO906 (Patupilone)DRUG -
doxorubicinDRUG -
epothilone bDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites149

Inclusion Criteria: * 18 years of age or older * Confirmed diagnosis of ovarian, fallopian or peritoneal cancer * No more than three chemotherapy regimens * Most recent regimen must have been platinum based Exclusion Criteria: * Have an unresolved bowel obstruction * Have had previous chemotherap...

Countries:United StatesAustraliaCanadaDenmarkFinlandFranceGreeceItalyPolandSouth AfricaSpainUnited KingdomNetherlandsSlovakiaCzechia
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Frequently asked questions about epothilone b

What is epothilone B used for?

Epothilone B is an investigational small molecule being studied in oncology for several solid tumor types, including breast, colorectal, kidney, ovarian and prostate cancers and melanoma. It is in Phase 2 clinical development and has not been approved for any indication.

What does epothilone B target?

Epothilone B targets tubulin, binding beta-tubulin subunits including TUBB4B, TUBB1 and TUBB3 and alpha-tubulin subunits such as TUBA1A, TUBA3C and TUBA4A. It acts as a tubulin stabiliser, promoting microtubule assembly and interfering with cell division in tumor cells.

Who is developing epothilone B?

Epothilone B is being developed by Novartis AG, which trades under the ticker NVS. The compound, also known as EPO906, has been studied in Novartis-sponsored Phase 2 oncology trials.

What phase is epothilone B in?

Epothilone B is in Phase 2 clinical development. It is investigational and has not received FDA approval. Its clinical program includes completed Phase 2 studies in kidney cancer, melanoma, breast cancer and prostate cancer.

What clinical trials is epothilone B in?

Epothilone B has been evaluated in completed Phase 2 trials including NCT00035243 in advanced kidney cancer, NCT00035165 in advanced melanoma, NCT00035126 in advanced breast cancer and NCT00035113 in prostate cancer. These studies enrolled adults and were conducted in the United States and France.

Is epothilone B the same as EPO906?

Yes, EPO906 is an alternative name for epothilone B. Both names refer to the same investigational Novartis compound, a small molecule tubulin stabiliser studied in Phase 2 oncology trials.