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Epothilone D

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

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 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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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, specifically in patients with HER-2 positive advanced or metastatic breast cancer. It is being developed by Roche Holding AG and is currently in Phase 1 clinical development.

What does Epothilone D target?

Epothilone D is a small molecule that targets microtubules, a component of the cell's cytoskeleton. By stabilizing microtubules, it disrupts cell division, which can lead to cancer cell death. This mechanism is similar to that of taxanes, but Epothilone D is a distinct chemical entity.

Who makes Epothilone D?

Epothilone D is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded on the OTC market under the ticker symbol RHHBY. The drug is currently in Phase 1 clinical trials for breast cancer.

What phase is Epothilone D in?

Epothilone D is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a Phase 1 trial for HER-2 positive advanced or metastatic breast cancer, which has been completed.

What clinical trials is Epothilone D in?

Epothilone D has been studied in one clinical trial, identified by the NCT number NCT00337649. This was a Phase 1 study of Epothilone D in combination with Herceptin (trastuzumab) in patients with HER-2 positive advanced or metastatic breast cancer. The trial was completed and enrolled 27 female participants in Spain.

Is Epothilone D the same as Ixabepilone?

No, Epothilone D is not the same as Ixabepilone. While both are epothilone derivatives that stabilize microtubules, they are distinct chemical compounds. Epothilone D is being developed by Roche, whereas Ixabepilone is a different drug that has been approved for breast cancer under the brand name Ixempra.