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PTK787/ZK 222584

Phase 3

Von Hippel-Lindau Disease | Small molecule | Oncology |Novartis AG|Trials Updated: Feb 10, 2020

PTK787/ZK 222584 development status

Highest phase Phase 3 (NCT00056459)
Phase scored for NVSPhase 2
Registered trials 4 across 3 sponsors since Jan 2003

PTK787/ZK 222584 target and mechanism

ModalitySmall molecule

Also known as PTK787, Vatalanib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials5
Total Enrollment2,106

FDA Designations

No designations recorded

PTK787/ZK 222584 clinical trials

PTK787/ZK 222584 · 5 trials · 9 indications

Phase 3 2Phase 2 1Phase 1 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
Evaluate efficacy
Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months
up to 12 months
Safety
Tolerability

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
PTK787/ZK 222584EXPERIMENTAL -
3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
VatalanibDRUG -
PTK787/ZK 222584DRUG -
PTK787DRUGVisudyne® + PTK787, 500 mg/day
PlaceboDRUGVisudyne® + Placebo
PTK787/ZK 222584 (vatalanib)DRUG -
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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 PTK787/ZK 222584

What is PTK787/ZK 222584?

PTK787/ZK 222584, also known as vatalanib, is an investigational small molecule studied in oncology and related conditions. It has been evaluated in tumors, Von Hippel-Lindau disease, and wet age-related macular degeneration. It is being developed by Novartis AG (ticker NVS) and remains in clinical development.

What is PTK787/ZK 222584 used for?

PTK787/ZK 222584 has been studied for tumors and neoplasm metastasis, Von Hippel-Lindau disease including CNS and retinal hemangioblastoma, and wet age-related macular degeneration. These are investigational uses evaluated in clinical trials, not approved indications.

Who makes PTK787/ZK 222584?

PTK787/ZK 222584 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trials evaluating the compound across oncology and ophthalmology indications.

What phase is PTK787/ZK 222584 in?

PTK787/ZK 222584 is in Phase 1 development overall, with completed Phase 1 and Phase 2 trials. It is investigational and has not been approved by the FDA for any indication. No trials are currently active.

What clinical trials is PTK787/ZK 222584 in?

Completed trials include NCT00171587, a Phase 1 study of vatalanib with capecitabine in advanced cancer; NCT00138632, a Phase 1 study in wet age-related macular degeneration; and NCT00052013, a Phase 2 study in Von Hippel-Lindau related hemangioblastoma. All three trials are completed.

Is PTK787/ZK 222584 the same as vatalanib?

Yes, PTK787/ZK 222584 is also known as vatalanib, and is sometimes referred to simply as PTK787. These names refer to the same investigational small molecule developed by Novartis AG.