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A Phase 1 Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-MIF Antibody in Subjects With Malignant Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Solid Tumors

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Trial Information

A Phase 1 Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-MIF Antibody in Subjects With Malignant Solid Tumors


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality

Outcome Time Frame:

14 months

Safety Issue:

Yes

Principal Investigator

Mahmoud Loghman-Adham, MD

Investigator Role:

Study Director

Investigator Affiliation:

Baxter Healthcare Corporation

Authority:

United States: Food and Drug Administration

Study ID:

391101

NCT ID:

NCT01765790

Start Date:

June 2012

Completion Date:

January 2014

Related Keywords:

  • Malignant Solid Tumors
  • Neoplasms

Name

Location

Scottsdale HealthcareScottsdale, Arizona  85251
Florida Cancer Specialists / Sarah Cannon Research InstituteSarasota, Florida  34232
Department of Investigator Cancer Therapeutics, University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
Cancer Therapy and Research Center (CTRC), The University of Texas Health Science Center at San AntonioSan Antonio, Texas  78229