Recent Updates
Recently added Catalysts

AVE0005

Phase 1

Colorectal Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: Nov 9, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

AVE0005 · 1 trial · 2 indications

Phase 1 1
NCT00921661Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal CancerColorectal Neoplasms
COMPLETED16 Analytics
PHASE1COMPLETED
Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer
Colorectal Neoplasms
NCT0092166116
Unlock trial analytics

Study Endpoints

Primary Endpoints

Dose-limiting toxicity (DLT) combination with FOLFIRI
During the first 2 cycles (4 weeks) of study treatment

Secondary Endpoints

physical examination, laboratory safety tests, adverse events
up to 60 days after last treatment
Pharmacokinetics
up to 90 days after last treatment
Tumor burden, endogenous free VEGF
every 3 cycles
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AVE0005 (aflibercept)EXPERIMENTAL -

Interventions

NameTypeDescription
AVE0005 (aflibercept)DRUGIV infusion
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with histologically or cytologically proven malignant tumor of the colon or rectum which is metastatic and inoperable. * Patients must have received at least one prior line of treatment with any standard of care, who have failed the treatment, or who have not been eli...

Countries:Japan
Unlock Eligibility Criteria

Frequently asked questions about AVE0005

What is AVE0005 used for?

AVE0005 is an investigational small molecule being studied for the treatment of colorectal neoplasms, specifically metastatic colorectal cancer. It is being developed by Sanofi (SNY) and is currently in Phase 1 clinical development. The drug is not approved and remains under investigation.

Who makes AVE0005?

AVE0005 is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. The drug is an investigational small molecule in Phase 1 clinical development for the treatment of colorectal neoplasms, including metastatic colorectal cancer.

What phase is AVE0005 in?

AVE0005 is in Phase 1 clinical development. It is an investigational small molecule being studied for colorectal neoplasms, including metastatic colorectal cancer. The drug is not FDA approved and remains under clinical investigation.

What clinical trials is AVE0005 in?

AVE0005 has one completed clinical trial, NCT00921661, titled 'Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer.' This Phase 1 study enrolled 16 participants in Japan and was not randomized, double-blind, or controlled.

Is AVE0005 the same as aflibercept?

AVE0005 is also known as aflibercept, as indicated by the clinical trial title for NCT00921661. In this context, AVE0005 refers to the investigational small molecule aflibercept being studied in combination with FOLFIRI for metastatic colorectal cancer in Japanese patients.