PARAMETER

DATA

Manufacturer

Amgen Incorporated

Indication

Vectibix is an epidermal growth factor receptor antagonist indicated as a single agent for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens. Approval is based on progression-free survival; no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.

Cell Substrate

Genetically engineered mammalian (Chinese Hamster Ovary) cells.

Manufacturing platform

Panitumumab is produced from Chinese Hamster Ovary (CHO) cells and purified by a series of chromatography steps, viral inactivation step, viral filtration step and ultrafiltration/diafiltration steps. The expression plasmid containing the genes for the heavy and light chains was transfected into CHO cells. Following cloning and sub-cloning steps, one clone producing panitumumab at high levels was selected as lead cell line. A two-tiered cell banking system of Master Cell bank (MCB) and Working Cell Bank (WCB) has been developed and maintained in accordance to cGMP and ICH guidelines.

Dose in vial/final container

Single-use vials (20 mg/mL): 100 mg/5 mL, 200 mg/10 mL, 400 mg/20 mL.

Dose to patient

6 mg/kg every 14 days as an intravenous infusion over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg)

NCT

TRIAL PHASE

NO OF PATIENTS ENROLLED

STUDY TITLE

COUNTRIES

Monotherapy (mCRC)

NCT00113763

3

463

Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients with Metastatic Colorectal Cancer

-

NCT00113776

2

-

Evaluating ABX-EGF Extended Therapy in Subjects with Metastatic Colorectal Cancer

-

NCT00083616

2

185

Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients with Metastatic Colorectal Cancer Following Treatment with Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

-

NCT00089635

2

203

Panitumumab (ABX-EGF) Monotherapy in Patients with Metastatic Colorectal Cancer

-

NCT00111774

2

150

Evaluating ABX-EGF in Patients with Metastatic Colorectal Carcinoma

-

Solid Tumors

NCT00425204

2

31

Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment

-

NCT00091806

1

86

Two Dose Schedules of Panitumumab in Subjects with Advanced Solid Tumors

-

NCT00101920

2

50

ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

-

NCT00425035

2

115

Safety and Efficacy Study of ABX-EGF in Patients with Renal Cancer, Part 2

-

Combination Therapy

NCT00111761

2

43

Evaluating Panitumumab (ABX-EGF) in Patients with Metastatic Colorectal Cancer

-

NCT00034346

2

194

ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

-