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

NCT01327612 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-02-21

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-03
Primary Completion
2020-02-05
Completion
2020-02-05

Countries

  • United States
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01327612 on ClinicalTrials.gov