NCT02266355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

3.3 years

First QC Date

October 10, 2014

Last Update Submit

May 28, 2019

Conditions

Colon Cancer

Keywords

OxaliplatinOmalizumab

Outcome Measures

Primary Outcomes (1)

  • Incidence of Recurrent HSR

    Recurrent Oxaliplatin HSR in subjects treated with omalizumab

    up to 12 months

Secondary Outcomes (1)

  • Safety of Omalizumab

    up to 12 months

Study Arms (1)

OmalizumabTreatment Group

EXPERIMENTAL

Omalizumab (Xolair) 300 mg SQ every 2 weeks

Drug: Omalizumab

Interventions

OmalizumabDRUG

Omalizumab 300 mg SQ every 2 weeks

Also known as: Xolair
OmalizumabTreatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Stacey Stein, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 17, 2014

Study Start

November 1, 2014

Primary Completion

February 27, 2018

Study Completion

February 27, 2018

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

US(1)