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ziv-aflibercept

Phase 2FDA approved

Cancer | Monoclonal antibody | Oncology |Regeneron Pharmaceuticals, Inc.|Trials Updated: Jun 3, 2016

ziv-aflibercept development status

FDA approval on record Aug 3, 2012 as Zaltrap
Approval holderSanofi Aventis Us
ApplicationBLA125418
Highest phase Phase 2 (NCT03712904)
Phase scored for REGNPhase 1
Registered trials 7 across 4 sponsors since Jan 2003

Label indication ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. FDA label

ziv-aflibercept target and mechanism

Molecular targetPGF, VEGFA
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials4
Total Enrollment50

FDA Designations

No designations recorded

ziv-aflibercept clinical trials

ziv-aflibercept · 4 trials · 3 indications

Phase 1 4
NCT00082823Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's LymphomaCancer
COMPLETED25 Analytics
NCT00083213Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's LymphomaCancer
COMPLETED25 Analytics
NCT00045266VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's LymphomaLymphoma
COMPLETED- Analytics
NCT00036946VEGF Trap in Treating Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin's LymphomaLymphoma
COMPLETED- Analytics
PHASE1COMPLETED
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
CancerUnlock trial analytics
PHASE1COMPLETED
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
CancerUnlock trial analytics
PHASE1COMPLETED
VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
LymphomaUnlock trial analytics
PHASE1COMPLETED
VEGF Trap in Treating Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin's Lymphoma
LymphomaUnlock trial analytics

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
ziv-afliberceptBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 120 Years
SexALL
Healthy VolunteersNo
Study Sites2

DISEASE CHARACTERISTICS: * Histologically confirmed non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites: * Liver * Soft tissue * Pelvis * Other site that is suitable for delayed contrast-enhancing MRI * Relapsed or refractory disease ...

Countries:United States
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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about ziv-aflibercept

What is ziv-aflibercept used for?

Ziv-aflibercept is being studied in cancer and lymphoma, specifically in adults with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma. The clinical program has focused on patients whose disease has returned or stopped responding to prior treatment. It remains an investigational therapy in Phase 1 development.

What does ziv-aflibercept target?

Ziv-aflibercept targets PGF and VEGFA, two proteins that promote blood vessel growth. It is an inhibitor that binds these vascular endothelial growth factor pathway ligands, aiming to block the signaling that supports tumor angiogenesis. This mechanism is being explored in oncology settings.

Who is developing ziv-aflibercept?

Regeneron Pharmaceuticals, Inc. is developing ziv-aflibercept. The company trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor associated with the clinical development program for this monoclonal antibody in oncology.

What phase is ziv-aflibercept in?

Ziv-aflibercept is in Phase 1 clinical development. It is an investigational agent and has not been established as approved for the cancer and lymphoma indications being studied. The Phase 1 program enrolled adults with advanced solid tumors or non-Hodgkin's lymphoma.

What clinical trials is ziv-aflibercept in?

Ziv-aflibercept has been evaluated in Phase 1 trials including NCT00083213, NCT00082823, NCT00045266, and NCT00036946. These studies treated adults with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma in the United States. All listed trials are completed, and no trials are currently active.

How many patients were enrolled in ziv-aflibercept trials?

Across the reported Phase 1 studies, total enrollment was approximately 50 patients. The trials were uncontrolled, non-randomized, and not double blinded, and they enrolled adults aged 18 years and older with advanced solid tumors or non-Hodgkin's lymphoma. Enrollment figures for some individual studies were not reported.