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AVE8062

Phase 1

Advanced Neoplastic Disease | Small molecule | Oncology |Sanofi|Last Updated: Jul 25, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

AVE8062 · 1 trial · 1 indication

Phase 1 1
NCT01907685Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid TumorsAdvanced Neoplastic Disease
COMPLETED58 Analytics
PHASE1COMPLETED
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors
Advanced Neoplastic DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose Limiting Toxicities (DLTs)
3 weeks (cycle 1)

Secondary Endpoints

Number of Participants with Adverse Events
Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles)
Plasma concentration of AVE8062 and its metabolite
Before AVE8062 infusion, immediately prior to the end of AVE8062 infusion, 5, 10, 25, 45 and 60 minutes then 2, 4, 6, 8-10 and 24 hours post AVE8062 infusion (cycle 1)
Plasma concentration of docetaxel
Before docetaxel infusion (corresponding to 24 hours post AVE8062 infusion), 15 minutes before the end of docetaxel infusion, 15 and 45 minutes post docetaxel infusion (cycle 1)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AVE8062 / DocetaxelEXPERIMENTALAVE8062 30-minute IV, 11.5 to 42 mg/m2, followed by Docetaxel, 1-hour IV, 75 and 100 mg/m2 in 3-week cycles until disease progression or unacceptable toxicity or study discontinuation criteria

Interventions

NameTypeDescription
AVE8062DRUGPharmaceutical form:Solution for infusion Route of administration: Intravenous
DocetaxelDRUGPharmaceutical form: solution for infusion Route of administration: Intravenous
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Advanced neoplastic disease (i.e metastatic or locally advanced disease) for which docetaxel-based regimen therapy is indicated such as breast, non-small cell lung and prostate cancer. * ECOG performance status of 0 to 1. Exclusion criteria: * Concurrent treatment with any o...

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Frequently asked questions about AVE8062

What is AVE8062 used for?

AVE8062 is an investigational small molecule being studied for the treatment of advanced neoplastic disease, a type of cancer. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with advanced solid tumors.

Who makes AVE8062?

AVE8062 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.

What phase is AVE8062 in?

AVE8062 is in Phase 1 clinical development. This early-stage trial is designed to assess the drug's safety, tolerability, and pharmacokinetics in patients with advanced solid tumors. The drug is investigational and has not yet received regulatory approval.

What clinical trials is AVE8062 in?

AVE8062 has one completed clinical trial registered under NCT01907685. This Phase 1 study, titled "Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors," enrolled 58 participants with advanced neoplastic disease.

How is AVE8062 being studied?

AVE8062 is being studied in a Phase 1, open-label, uncontrolled clinical trial. The study combines AVE8062 with docetaxel in patients with advanced solid tumors. The trial is not randomized or double-blinded, and it does not use a control group or biomarker selection.