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vatalanib

Phase 3

Colorectal Neoplasms | Small Molecules | Oncology |Novartis AG|Trials Updated: Feb 10, 2020

vatalanib development status

Highest phase Phase 3
Registered trials 3 across 3 sponsors since Mar 2003

vatalanib target and mechanism

Molecular targetPDGFRB, PDGFRA, FLT1, FLT4, KDR, CSF1R
Target classInhibitor
ModalitySmall Molecules

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment2,046

FDA Designations

No designations recorded

vatalanib clinical trials

vatalanib · 3 trials · 4 indications

Phase 3 2Phase 2 1
NCT00056459Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.Colorectal Neoplasms
COMPLETED1,168 Analytics
NCT00056446Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal CancerColorectal Neoplasms
COMPLETED855 Analytics
PHASE3COMPLETED
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.
Colorectal NeoplasmsUnlock trial analytics
PHASE3COMPLETED
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
Colorectal NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression free survival
Throughout duration of study
Overall survival
throughout duration of study
Change in biochemical markers.
Quarterly= every 3 months

Secondary Endpoints

Time to progression
Throughout duration of study
Time to treatment failure
Throughout duration of study
Best overall response rate
Throughout duration of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALOxaliplatin/5-FU/LV and PTK787/ZK 222584
2PLACEBO_COMPARATOROxaliplatin/5-FU/LV and placebo

Interventions

NameTypeDescription
VatalanibDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites223

Inclusion criteria: * Patients with metastatic colorectal cancer coming for initial chemotherapy * Documented metastatic colorectal cancer * WHO Performance Status of 0, 1, or 2 * Measurable tumors * Adequate hematologic status, liver and kidney function * Life expectancy greater than 12 weeks * Wr...

Countries:United StatesAustraliaBelgiumBrazilCanadaCzechiaFranceGermanyHungaryItalyNetherlandsNew ZealandPortugalSlovakiaSpainSwedenSwitzerlandTaiwanUnited KingdomAustriaHong Kong
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Frequently asked questions about vatalanib

What is Vatalanib?

Vatalanib is an investigational oral small molecule kinase inhibitor developed by Novartis AG for oncology indications. It has been studied in metastatic colorectal cancer and metastatic neuroendocrine tumors. Vatalanib is not described as approved and remains an investigational agent that has completed Phase 3 clinical testing in colorectal cancer.

What does Vatalanib target?

Vatalanib is a multi-kinase inhibitor that targets PDGFRB, PDGFRA, FLT1, FLT4, KDR, and CSF1R. These receptors include vascular endothelial growth factor receptors and platelet-derived growth factor receptors, plus colony stimulating factor 1 receptor. By inhibiting these kinases, Vatalanib acts on pathways involved in tumor angiogenesis and the tumor microenvironment.

Who makes Vatalanib?

Vatalanib is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical development program for the drug, including the Phase 3 colorectal cancer studies and the Phase 2 study in metastatic neuroendocrine tumors.

What phase is Vatalanib in?

Vatalanib has reached Phase 3 clinical development. Two Phase 3 trials in metastatic colorectal cancer and one Phase 2 trial in metastatic neuroendocrine tumors are listed as completed, with no active trials currently recorded. Vatalanib is an investigational agent and is not described as FDA approved.

What clinical trials is Vatalanib in?

Vatalanib has been evaluated in completed trials including NCT00056459, a Phase 3 study of oxaliplatin/5-FU/leucovorin plus Vatalanib versus chemotherapy alone in metastatic colorectal cancer with 1,168 patients, and NCT00056446, a Phase 3 study in previously treated metastatic colorectal cancer with 855 patients. NCT00590343 was a Phase 2 study in metastatic neuroendocrine tumors with 23 patients.