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Non pegylated liposomal doxorubicin and docetaxel

Phase 2

Breast Cancer | Small molecule | Oncology |Sanofi|Last Updated: Oct 6, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

Non pegylated liposomal doxorubicin and docetaxel · 1 trial · 2 indications

Phase 2 1
NCT00377559Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast CancerBreast Cancer
COMPLETED70 Analytics
PHASE2COMPLETED
Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer
Breast Cancer
NCT0037755970
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Study Endpoints

Primary Endpoints

Cardiotoxicity (definite or probable cardiac death)
treatment period
Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV
treatment period
Decline in left ventricular ejection fraction (LVEF) of ≥ 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III)
treatment period
Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF
treatment period

Secondary Endpoints

Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification
treatment period
Response rate
treatment period
Median time to progression
treatment period
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1.EXPERIMENTALMyocet+docetaxel

Interventions

NameTypeDescription
Non pegylated liposomal doxorubicin and docetaxelDRUGmax. 6 courses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Women with histologically documented metastatic or locally advanced metastatic HER2/neu negative breast cancer. * In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or taxanes, this must have been completed more than 12 months before inclusion. * ...

Countries:Netherlands
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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 Non pegylated liposomal doxorubicin and docetaxel

What is Non pegylated liposomal doxorubicin and docetaxel used for?

Non pegylated liposomal doxorubicin and docetaxel is used for breast cancer, specifically in HER2 negative metastatic breast cancer. It is a combination of two small molecule drugs being studied as a treatment for this condition.

Who makes Non pegylated liposomal doxorubicin and docetaxel?

Sanofi (ticker: SNY) is developing Non pegylated liposomal doxorubicin and docetaxel. The drug is currently in Phase 2 clinical development for breast cancer.

What phase is Non pegylated liposomal doxorubicin and docetaxel in?

Non pegylated liposomal doxorubicin and docetaxel is in Phase 2 clinical development. It is an investigational combination therapy for breast cancer and is not yet approved by regulatory authorities.

What clinical trials is Non pegylated liposomal doxorubicin and docetaxel in?

Non pegylated liposomal doxorubicin and docetaxel has one completed clinical trial, NCT00377559, titled 'Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer'. This Phase 2 trial enrolled 70 participants in the Netherlands.

Is Non pegylated liposomal doxorubicin and docetaxel the same as liposomal doxorubicin?

Non pegylated liposomal doxorubicin and docetaxel is a combination of two drugs: non pegylated liposomal doxorubicin and docetaxel. It is not the same as liposomal doxorubicin alone, as it includes docetaxel as a second component.