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Epothilone D

Phase 2

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Trials Updated: Apr 28, 2023

Epothilone D development status

Highest phase Phase 2 run by Bristol-Myers Squibb (NCT00104130)
Phase scored for RHHBYPhase 1
Registered trials 3 across 2 sponsors since Apr 2004

Epothilone D target and mechanism

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

Also known as RO4598715, KOS-862

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Epothilone D clinical trials

Epothilone D · 1 trial · 1 indication

Phase 1 1
NCT00337649A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast CancerBreast Cancer
COMPLETED27 Analytics
PHASE1COMPLETED
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase I: Number of Participants with a Dose-Limiting Toxicity
From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
Phase II: Objective Response Rate (per RECIST criteria)
From first dose of study treatment until documented response (up to 3 years, 2 months)

Secondary Endpoints

Phase II: Duration of Response
From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Phase II: Time to Tumor Progression
From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Phase I: Plasma Concentration of Epothilone D at Specified Timepoints
Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase I - Epothilone D Dose EscalationEXPERIMENTAL -
Phase II - Epothilone D Maximum Tolerated DoseEXPERIMENTAL -

Interventions

NameTypeDescription
Epothilone DDRUG≤100 mg/m\^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks
HerceptinDRUG4mg/kg iv loading dose, followed by 2mg/kg iv weekly
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * women \>=18 years; * locally advanced or metastatic breast cancer; * HER-2 overexpression (FISH + or IHC 3+); * \>=1 measurable lesion; * up to one prior anthracycline-based chemotherapy regimen in a metastatic setting. Exclusion Criteria: * pre-existing neuropathy \>=grade ...

Countries:Spain
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Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about Epothilone D

What is Epothilone D used for?

Epothilone D is an investigational small molecule being studied for the treatment of breast cancer. It has been evaluated specifically in patients with HER-2 positive advanced or metastatic breast cancer, in combination with trastuzumab (Herceptin). It is not an approved therapy and remains in clinical development.

What does Epothilone D target?

Epothilone D targets tubulin proteins, including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as a tubulin stabiliser, binding to these targets to promote microtubule stabilization. This mechanism interferes with microtubule dynamics, which is relevant to its evaluation in breast cancer.

Who is developing Epothilone D?

Epothilone D is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating this agent in breast cancer.

What phase is Epothilone D in?

Epothilone D is in Phase 1 clinical development. It has not been approved by the FDA or any regulatory agency and is considered investigational. The Phase 1 program has completed one trial, with no active trials currently reported.

What clinical trials is Epothilone D in?

Epothilone D has been studied in one completed Phase 1 trial, NCT00337649, titled "A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer." The trial enrolled 27 female patients aged 18 years and older in Spain.