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ABX-EGF

Phase 2

Colorectal Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: May 14, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

ABX-EGF · 5 trials · 6 indications

Phase 2 5
NCT00327119Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal CancerMetastatic Colorectal Cancer
COMPLETED50 Analytics
NCT00101920ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer
COMPLETED50 Analytics
NCT00111774Evaluating ABX-EGF in Patients With Metastatic ColorectalCarcinomaColorectal Cancer
COMPLETED150 Analytics
NCT00034346ABX-EGF in Combination With Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)Non-Small Cell Lung Cancer
COMPLETED194 Analytics
NCT00113776Evaluating ABX-EGF Extended Therapy in Subjects With MetastaticColorectal CancerColorectal Cancer
COMPLETED- Analytics
PHASE2COMPLETED
Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal Cancer
Metastatic Colorectal CancerUnlock trial analytics
PHASE2COMPLETED
ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Lung CancerUnlock trial analytics
PHASE2COMPLETED
Evaluating ABX-EGF in Patients With Metastatic ColorectalCarcinoma
Colorectal CancerUnlock trial analytics
PHASE2COMPLETED
ABX-EGF in Combination With Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
Non-Small Cell Lung CancerUnlock trial analytics
PHASE2COMPLETED
Evaluating ABX-EGF Extended Therapy in Subjects With MetastaticColorectal Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Tumor Response
End of initial 6 week treatment period
To assess Objective Response at Week 8 of Cycle 1
Time to Disease Progression
Incidence of Adverse events
Changes in Lab values
Incidence of HAHA formation

Secondary Endpoints

To evaluate additional measures of the clinical efficacy of ABX-EGF in subjects with metastatic colorectal carcinoma. (progression free survival, survival time, best overall response, and time to disease progression)
To determine the safety of ABX-EGF in subjects with metastatic colorectal carcinoma. (incidence of AEs, laboratory abnormalities, and other safety parameters)
To evaluate the safety and efficacy of ABX-EGF in subjects with lower tumor epidermal growth factor receptor (EGFr) expression
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABX-EGFEXPERIMENTALOpen-label, single arm panitumamab monotherapy

Interventions

NameTypeDescription
ABX-EGF (panitumumab)DRUG -
ABX-EGFDRUG2.5 mg/kg by an infusion pump over one hour
paclitaxelDRUG -
carboplatinDRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Metastatic colorectal adenocarcinoma; * Subjects must have become refractory to treatment or unable to continue treatment due to toxicity or other reasons during or after treatment with fluoropyrimidine, irinotecan and oxaliplatin for metastatic colorectal cancer including tho...

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Frequently asked questions about ABX-EGF

What is ABX-EGF used for?

ABX-EGF is an investigational small molecule being studied for the treatment of colorectal cancer, metastatic colorectal cancer, and non-small cell lung cancer. It is in Phase 2 clinical development and has been evaluated in completed trials for these oncology indications.

Who makes ABX-EGF?

ABX-EGF is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 2 clinical development for oncology indications.

What phase is ABX-EGF in?

ABX-EGF is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients.

What clinical trials is ABX-EGF in?

ABX-EGF has been studied in several completed Phase 2 trials, including NCT00034346, NCT00101920, NCT00111774, and NCT00327119. These trials evaluated the drug in patients with non-small cell lung cancer, colorectal cancer, and metastatic colorectal cancer.

Is ABX-EGF the same as panitumumab?

Yes, ABX-EGF is also known as panitumumab. One clinical trial, NCT00327119, explicitly refers to ABX-EGF as panitumumab in its title, confirming that these names refer to the same investigational drug.