Recent Updates
Recently added Catalysts

Fixed-dose combination of capecitabine and cyclophosphamide SAR439281

Phase 2

Breast Cancer Metastatic | Small molecule | Oncology |Sanofi|Last Updated: Feb 1, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment2

FDA Designations

No designations recorded

Clinical trial landscape

Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 · 1 trial · 1 indication

Phase 2 1
NCT02664103Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast CancerBreast Cancer Metastatic
COMPLETED2 Analytics
PHASE2COMPLETED
Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer
Breast Cancer MetastaticUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of patients with adverse events
12 weeks
Assessment of PK parameter: maximum concentration (Cmax)
Daily 12 weeks
Assessment of PK parameter: time to reach Cmax (Tmax)
Daily 12 weeks

Secondary Endpoints

Disease Control Rate (DCR)
12 weeks
Objective Response Rate (ORR)
12 weeks
Time to Progression (TTP)
12 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR439281(Cohort 1)EXPERIMENTALRegimen 1: one full-dose tablet containing capecitabine and cyclophosphamide, given BID without interruption
SAR439281(Cohort 2)EXPERIMENTALRegimen 2: two tablets containing capecitabine and cyclophosphamide, given OD without interruption
SAR439281(Cohort 3)EXPERIMENTALRegimen 3: one tablet containing capecitabine and cyclophosphamide, given OD without interruption

Interventions

NameTypeDescription
Fixed-dose combination of capecitabine and cyclophosphamide SAR439281DRUGPharmaceutical form:Tablet Route of administration: Oral
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites5

Inclusion criteria: * Female ≥18 and ≤65 years old. * Patients with histologically or cytologically confirmed Metastatic Breast Cancer (HER2 negative, ER/PR positive or negative), who are candidates to receive capecitabine and cyclophosphamide as per Investigator's judgment, and meet either one of ...

Countries:India
Unlock Eligibility Criteria

Competitive Landscape -Breast Cancer 399 trials (matched to "Breast Cancer Metastatic")

Top 20 of 91 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN46PHASE3Fulvestrant, 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 CorpBCTX1PHASE3SV-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
Unlock Competitive Intelligence