Phase 1 Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Solid Tumors - Full Text View

Purpose

The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-MIF antibody in subjects with malignant solid tumors.

Condition	Intervention	Phase
Malignant Solid Tumors	Biological: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1 Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-MIF Antibody in Subjects With Malignant Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Number of participants experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Plasma pharmacokinetic parameters [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Maximum concentration (Cmax), minimum concentration (Cmin), area under the concentration vs time curve (AUC), half-life [t½], clearance (CL), mean residence time (MRT) and volume of distribution at steady state (VDss)
Tumor response [ Time Frame: 14 months ] [ Designated as safety issue: No ]
Change in levels of free active MIF and free total MIF levels following treatment with anti-MIF antibody [ Time Frame: 14 months ] [ Designated as safety issue: No ]
Change in levels of tumor-associated biomarkers following treatment with anti-MIF antibody [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	June 2012
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Anti-MIF Study Part 1: Dose Escalation Phase- Standard dose escalation in 4 dose groups of 3-6 participants each according to 3+3 design: 1. Dose escalation will be performed after safety data review, following completion of dosing of each cohort. -> 2. Safety data review. If dose escalation permissible -> 3. Next dose group -> 4. Safety data review, etc. Study Part 2: Expansion Phase- Approximately 20 additional participants will receive anti-MIF antibody (at the maximum tolerated dose or lower) in order to gain further experience with the investigational product at a specific dose level(s) and/or in particular patient or tumor types.	Biological: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody Intravenous injection

Arms

Assigned Interventions

Experimental: Anti-MIF

Study Part 1: Dose Escalation Phase- Standard dose escalation in 4 dose groups of 3-6 participants each according to 3+3 design: 1. Dose escalation will be performed after safety data review, following completion of dosing of each cohort. -> 2. Safety data review. If dose escalation permissible -> 3. Next dose group -> 4. Safety data review, etc.

Study Part 2: Expansion Phase- Approximately 20 additional participants will receive anti-MIF antibody (at the maximum tolerated dose or lower) in order to gain further experience with the investigational product at a specific dose level(s) and/or in particular patient or tumor types.

Biological: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody

Intravenous injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Males and females 18 years of age and older at the time of screening
Anticipated life expectancy > 3 months at the time of screening
Histologically confirmed malignant solid tumor which is refractory to or has failed standard treatments, or subject is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Adequate hematological function (as defined in the study protocol)
Adequate renal function (as defined in the study protocol)
Adequate liver function (as defined in the study protocol)
Adequate venous access

Main Exclusion Criteria:

Known brain tumors or Central nervous system (CNS) metastases
Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, or hormonal therapy) within 4 weeks prior to administration of the investigational product (IP) (6 weeks for nitrosoureas and mitomycin C). Any previous treatment-related toxicities must have recovered to Grade ≤ 1 (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03). Prior and concurrent use of hormone deprivation therapies for hormone-refractory prostate cancer or breast cancer are permitted.
Major surgery within 4 weeks prior to IP administration
Active infection requiring IV antibiotics within 2 weeks prior to screening
Known history of hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis. Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease.
Participant has received a live vaccine within 4 weeks prior to screening
Known hypersensitivity to any component of recombinant protein production by Chinese Hamster Ovary (CHO) cells
Participant has been exposed to an IP or investigational device in another clinical study within 4 weeks prior to IP administration, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765790

Contacts

Contact: Medical Information

medinfo@baxter.com

Locations

United States, Arizona
Scottsdale Healthcare	Recruiting
Scottsdale, Arizona, United States, 85258
United States, Florida
Florida Cancer Specialists / Sarah Cannon Research Institute	Recruiting
Sarasota, Florida, United States, 34232
United States, Texas
Department of Investigator Cancer Therapeutics, University of Texas, MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Cancer Therapy and Research Center (CTRC), The University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Study Director:

Mahmoud Loghman-Adham, MD

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT01765790 History of Changes
Other Study ID Numbers:	391101
Study First Received:	January 9, 2013
Last Updated:	January 9, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Antibodies
Immunoglobulins

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013