Role of Omalizumab in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT02266355
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Omalizumab 300 mg SQ every 2 weeks

Study Details

Pilot study to evaluate the activity of omalizumab in the prevention of recurrent oxaliplatin hypersensitivity reaction (HSR) in oxaliplatin-sensitive patients. The study will also evaluate the safety of omalizumab (Xolair) when administered in this setting.

Key Dates

Start date
Nov 30, 2014
Status verified
May 2019
Primary completion
Feb 27, 2018
Completion
Feb 27, 2018

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: OmalizumabTreatment Group
    Omalizumab (Xolair) 300 mg SQ every 2 weeks

Primary Outcome Measure

Incidence of Recurrent HSR [ Time Frame: up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06519-

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