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Vatalanib

Phase 3

Colorectal Neoplasms | Small molecule | Oncology |Novartis AG|Last Updated: Feb 10, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment2,023

FDA Designations

No designations recorded

Clinical trial landscape

Vatalanib · 2 trials · 3 indications

Phase 3 2
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

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 used for in colorectal cancer?

Vatalanib is an investigational small molecule being studied for the treatment of colorectal neoplasms, including metastatic colorectal cancer. It was evaluated in Phase 3 clinical trials in combination with oxaliplatin, 5-FU, and leucovorin in patients with previously treated metastatic colorectal cancer. Vatalanib is not approved and remains in clinical development.

What does Vatalanib target?

Vatalanib is a small molecule that targets vascular endothelial growth factor receptors, which play a role in tumor angiogenesis. By inhibiting these receptors, Vatalanib aims to disrupt the blood supply that tumors need to grow and spread. This mechanism was evaluated in Phase 3 trials for metastatic colorectal cancer.

Who makes Vatalanib?

Vatalanib is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. Novartis sponsored the Phase 3 clinical trials of Vatalanib in patients with metastatic colorectal cancer, which have been completed.

What phase is Vatalanib in?

Vatalanib is in Phase 3 clinical development, having completed two Phase 3 trials in metastatic colorectal cancer. These trials were randomized, double-blind, and placebo-controlled. Vatalanib is investigational and has not been approved by regulatory authorities, as it remains in clinical development.

What clinical trials is Vatalanib in?

Vatalanib was studied in two completed Phase 3 trials: NCT00056446, which enrolled 855 patients, and NCT00056459, which enrolled 1168 patients. Both trials evaluated Vatalanib combined with oxaliplatin, 5-FU, and leucovorin versus the same chemotherapy regimen without Vatalanib in patients with metastatic colorectal cancer.

Is Vatalanib the same as PTK787?

Vatalanib is also known by the alternative name PTK787, and both names refer to the same investigational drug. It is a small molecule developed by Novartis AG for the treatment of colorectal cancer. In clinical trials, it was tested in combination with standard chemotherapy for metastatic colorectal cancer.