NCT01327612

Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)

A Phase 2 Open Label Extension Study of Conatumumab and AMG 479

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this protocol is to allow continued treatment with conatumumab and/or ganitumab, with or without chemotherapy, to participants who completed a separate Amgen-sponsored conatumumab or ganitumab study without disease progression whose previous studies were closed.

Conditions

• Advanced Solid Tumors
• Carcinoid
• Colorectal Cancer
• Locally Advanced
• Lymphoma
• Metastatic Cancer
• Non-Small Cell Lung Cancer
• Sarcoma
• Solid Tumors

Interventions

Type	Name	Description
DRUG	Modified FOLFOX6	The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days.
BIOLOGICAL	Conatumumab	Administered by intravenous infusion Q2W or Q3W.
BIOLOGICAL	Ganitumab	Administered by intravenous infusion Q3W or Q4W.
BIOLOGICAL	Bevacizumab	Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.

Timeline

• Start date: 2011-03-03
• Primary completion: 2020-02-05
• Completion: 2020-02-05
• First posted: 2011-04-01
• Last updated: 2021-02-21
• Results posted: 2021-02-21

Locations

12 sites across 3 countries: United States, Poland, Spain