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XRP9881

Phase 3

Breast Cancer | Small molecule | Oncology |Sanofi|Trials Updated: Jun 3, 2016

XRP9881 development status

Highest phase Phase 3 (NCT00081796)
Phase scored for SNYPhase 2
Registered trials 3 across 1 sponsor since Apr 2004

XRP9881 target and mechanism

ModalitySmall molecule

Also known as larotaxel

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials8
Total Enrollment1,772

FDA Designations

No designations recorded

XRP9881 clinical trials

XRP9881 · 8 trials · 8 indications

Phase 3 3Phase 2 4Phase 1 1
NCT00625664Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder CancerUrinary Bladder Neoplasms
COMPLETED337 Analytics
NCT00417209Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing RegimenPancreatic Neoplasms
COMPLETED408 Analytics
NCT00081796Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast CancerBreast Cancer
COMPLETED438 Analytics
PHASE3COMPLETED
Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Urinary Bladder NeoplasmsUnlock trial analytics
PHASE3COMPLETED
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen
Pancreatic NeoplasmsUnlock trial analytics
PHASE3COMPLETED
Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
study period
overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause
study period
Time to tumor progression.
Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.
treatment period
Tumor response measured
every 2 cycles during treatment phase
Response rate (best overall response under treatment)
study period
Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors
Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine
study period

Secondary Endpoints

Radiological tumor assessments (CT/MRI)
at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression
Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status
at screening and every cycle
Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms;
study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Larotaxel (XRP9881)EXPERIMENTAL -
5-Fluorouracil or capecitabineACTIVE_COMPARATOREach Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site.
Arm A1EXPERIMENTALCohort 1: Her2-ve breast cancer
Arm B1ACTIVE_COMPARATORCohort 1: Her2-ve breast cancer
Arm A2EXPERIMENTALCohort 2: Her2+ve breast cancer
Arm B2ACTIVE_COMPARATORCohort 2: Her2+ve breast cancer
Larotaxel + TrastuzumabEXPERIMENTAL -
larotaxel + CapecitabineEXPERIMENTAL -

Interventions

NameTypeDescription
larotaxel (XRP9881)DRUGadministered on day 1 as a 1-hour infusion
gemcitabineDRUGadministered on day 1, 8 and 15 as a 30-minute infusion
cisplatinDRUG1 hour infusion administered on day 1, 30 minutes after the other treatment
5-FluorouracilDRUGadministered as IV infusion from Day 1 to Day 4
CapecitabineDRUGadministered orally from Day 1 to Day 14 q3w
larotaxel (RPR109881, XRP9881)DRUG -
docetaxelDRUGintravenous administration
trastuzumabDRUGintravenous administration
XRP9881DRUG -
larotaxelDRUGIV infusion on Day 1 of a 21-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites160

Inclusion Criteria: * Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer * ECOG Performance Status 0 or 1 * No prior palliative chemotherapy Exclusion Criteria: * (Neo)Adjuvant chemotherapy if \...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileFranceIndiaIsraelItalyMexicoNetherlandsPolandRussiaSouth AfricaSpainSwedenTurkey (Türkiye)ColombiaCzechiaFinlandGermanyHungaryNorwayPeruSlovakiaUnited KingdomAustriaNew ZealandPortugalRomaniaSloveniaSouth KoreaTaiwanTunisiaUruguaySwitzerlandDenmark
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Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about XRP9881

What is XRP9881 used for in breast cancer?

XRP9881 is an investigational small molecule being studied for the treatment of advanced breast cancer. It is intended for patients whose disease no longer responds to anthracycline, taxane, and capecitabine treatment. The drug is administered intravenously and is currently in clinical development, not yet approved.

Who makes XRP9881?

XRP9881 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical research on this investigational oncology drug for the treatment of advanced breast cancer.

What phase is XRP9881 in?

XRP9881 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under investigation for its potential use in advanced breast cancer.

What clinical trials is XRP9881 in?

XRP9881 has been studied in one clinical trial with the identifier NCT00087958. This Phase 2 trial was a completed, uncontrolled study that enrolled 168 patients with advanced breast cancer who no longer responded to anthracycline, taxane, and capecitabine treatment. The trial was conducted across multiple countries.

Is XRP9881 the same as RPR109881?

Yes, XRP9881 is also known as RPR109881. The clinical trial NCT00087958, which studied this drug, is titled "Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment." Both names refer to the same investigational drug.