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AG-013726

Phase 1

Colorectal Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Dec 6, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment187

FDA Designations

No designations recorded

Clinical trial landscape

AG-013726 · 1 trial · 1 indication

Phase 1 1
NCT00460603Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal CancerColorectal Neoplasms
COMPLETED187 Analytics
PHASE1COMPLETED
Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
Colorectal NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Objective Response: Phase 2
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)

Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as \>=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study \>=4 weeks after initial documentation of response.

Secondary Endpoints

Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1
Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BACTIVE_COMPARATORbevacizumab 5 mg/kg every 2 weeks + FOLFOX
CEXPERIMENTALAG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX
AEXPERIMENTALAG-013736 5 mg bid starting dose + FOLFOX

Interventions

NameTypeDescription
bevacizumabDRUGbevacizumab 5 mg/kg every 2 weeks
AG-013726DRUGAG-013726 5 mg bid every 2 weeks
AG-013736 (axitinib)DRUGAG-013736 5 mg bid starting dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites106

Inclusion Criteria: * (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment * (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy. * Patient...

Countries:United States
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Frequently asked questions about AG-013726

What is AG-013726 used for?

AG-013726 is an investigational small molecule being studied for the treatment of colorectal neoplasms, specifically in patients with metastatic colorectal cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes AG-013726?

AG-013726 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for colorectal neoplasms.

What phase is AG-013726 in?

AG-013726 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of colorectal neoplasms, including metastatic colorectal cancer.

What clinical trials is AG-013726 in?

AG-013726 has been studied in one completed Phase 1 clinical trial, NCT00460603, which evaluated the drug in combination with chemotherapy and bevacizumab in patients with metastatic colorectal cancer. The trial enrolled 187 participants in the United States.

Is AG-013726 the same as AG-013736?

AG-013726 is the drug name provided, while the clinical trial NCT00460603 refers to AG-013736. The relationship between these two names is not specified, and they may refer to the same compound or different compounds.