Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

Angiogenesis Inhibitors

Panitumumab

Imetelstat

Motesanib diphosphate

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

Maximum Tolerated Dose of AMG 706 established in Part 1b + FOLFOX-4

Maximum Tolerated Dose of AMG 706 established in Part 1b + FOLFIRI

75 mg QD AMG 706 + panitumumab + FOLFOX-4

75 mg BID AMG 706 + panitumumab + FOLFIRI

125 mg QD AMG 706 + panitumumab + FOLFIRI

100 mg QD AMG 706 + panitumumab + FOLFIRI

50 mg QD AMG 706 + panitumumab + FOLFOX-4

The FOLFOX-4 regimen will be administered every 2 weeks as follows:

Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed

FOLFOX-4

AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.

AMG 706

Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.

Panitumumab (Part 1a only)

Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.

FOLFIRI

The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with either FOLFIRI or FOLFOX4 chemotherapy regimens. This is a Phase 1b clinical study.

Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer

An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer

Spots Global Cancer Trial Database for Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial