Role of Omalizumab in Reducing the Incidence of Oxaliplat... | NCT02266355

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

NCT02266355

Sponsor

Yale University

Status

Completed

Last Update Posted

May 30, 2019Actual

Enrollment

9Actual

Phase

Phase 1

Conditions

Colon Cancer

Interventions

Omalizumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Feb 27, 2018Actual

Completion Date

Feb 27, 2018Actual

First Submitted Date

Oct 10, 2014

First Submission Date that Met QC Criteria

Oct 16, 2014

First Posted Date

Oct 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2019

Last Update Posted Date

May 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

This is an open label single arm pilot study studying the effects of omalizumab in the treatment of oxaliplatin hypersensitivity reaction (HSR) for patients with stage IV GI cancer.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
OmalizumabTreatment Group	Experimental	Omalizumab (Xolair) 300 mg SQ every 2 weeks	Drug: Omalizumab

Name	Type	Description	Arm Group Labels	Other Names
Omalizumab	Drug	Omalizumab 300 mg SQ every 2 weeks	OmalizumabTreatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Recurrent HSR	Recurrent Oxaliplatin HSR in subjects treated with omalizumab	up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Safety of Omalizumab	Evaluate the safety of omalizumab by assessment of frequency of adverse events and serious adverse events as categorized by CTCAE version 4	up to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically evident HSR to oxaliplatin, with symptoms of flushing, urticaria, pruritus, rash, and/or dyspnea without bronchospasm that emerge during or shortly after of oxaliplatin infusion
Responding (complete or partial) or stable disease according to RECIST criteria while undergoing treatment with oxaliplatin containing regimen or need to resume an oxaliplatin based regimen in the setting of well-documented recent oxaliplatin hypersensitivity reaction
Histologically confirmed stage IV GI cancer (AJCC 7th edition) currently sensitive to oxaliplatin containing chemotherapy regimen
Age 18 years or older
ECOG performance status 0-2
Adequate bone marrow, liver, and kidney function. (WBC > 1500 cells/uL, platelets > 50,000/uL, ALT/AST < 5xULN (unless due to liver metastasis), Creatinine < 2.0 mg/ld)
Willing to give written informed consent, adhere to the visit schedules and meet study requirements

Exclusion Criteria:

Prior history of severe reactions to oxaliplatin as characterized by the presence of hemodynamic instability, significant respiratory symptoms or potential airway compromise
History of hypersensitivity reaction to Xolair or any ingredient of Xolair
Concurrent therapy with investigational agents
Use of any other investigational agent in the last 15 days and all toxicity of prior therapy resolved
Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule
Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding
Patients with severe medical conditions that in the view of the investigator prohibits participation in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins