NCT01521325

Brief Summary

This research is being conducted to determine the biodistribution of radiolabeled amatuximab in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or non small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

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

January 7, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

January 7, 2011

Last Update Submit

September 28, 2016

Conditions

MesotheliomaPancreatic CancerOvarian CancerNon-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue

    To determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissue in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or nonsmall cell lung cancer by performing SPECT imaging to determine binding to tumor and non-tumor tissue.

    1 year

Secondary Outcomes (5)

  • Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab

    1 year

  • Pharmacokinetic and serum levels

    1 year

  • uptake of Indium-CHX-A amatuximab

    1 year

  • occurrence of HACA

    1 year

  • correlate shed serum mesothelin to imaging

    1 year

Study Arms (1)

Amatuximab infusion

EXPERIMENTAL

Subjects will receive one infusion of radiolabeled amatuximab.

Drug: Amatuximab

Interventions

AmatuximabDRUG

Subjects will receive one infusion of radiolabeled amatuximab.

Also known as: MORAb-009, MORAB-009-006
Amatuximab infusion

Eligibility Criteria

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

You may qualify if:

  • Female and Male subjects \> or = 18 years of age
  • Histologically confirmed mesothelin-expressing cancer
  • Measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is \> or = 1.5cm, as defined by RECIST v1.1 and disease location, at discretion of the physician, or evaluable by clinical symptoms supported by biomarker, radiological or pathological studies conducted within 4 weeks prior to study entry

You may not qualify if:

  • Known allergy or hypersensitivity to monoclonal antibodies
  • Known to develop HACA
  • Prior treatment with amatuximab
  • Prior treatment with SS1 (dsFv)PE38 (ss1P)
  • Prior treatment with another test article within previous 30 days
  • Known brain metastasis
  • Known prosthetic devices that would prohibit imaging ow lesion of interest due to radiographic artifact
  • Chemotherapy, biological therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cacner Institue

Bethesda, Maryland, 20892', United States

Location

MeSH Terms

Conditions

MesotheliomaPancreatic NeoplasmsOvarian NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

amatuximab

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Raffit Hassan, MD

    National Institutes of Health (NIH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 30, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

US(1)