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

Baxalta now part of Shire5 sites in 2 countries68 target enrollmentJune 14, 2012

ConditionsMetastatic Adenocarcinoma of the Colon or Rectum Malignant Solid Tumors

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Adenocarcinoma of the Colon or Rectum
Sponsor: Baxalta now part of Shire
Enrollment: 68
Locations: 5
Primary Endpoint: Number of participants experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-MIF antibody in subjects with malignant solid tumors (Arm 1) and in subjects with metastatic adenocarcinoma of the colon or rectum (Arm 2).

Registry

clinicaltrials.gov

Start Date

June 14, 2012

End Date

July 28, 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baxalta now part of Shire

Responsible Party

Sponsor

Eligibility Criteria

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
•Arm 1 only: Histologically confirmed malignant solid tumor which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment
•Arm 2 only: Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the colon or rectum which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment
•Measurable or evaluable disease (as defined in the study protocol)
•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

Exclusion Criteria

•Known brain tumors or Central nervous system (CNS) metastases
•Myocardial infarction within 6 months of anti-MIF antibody administration, congestive heart failure (New York Heart Association Class III or Class IV), unstable angina, unstable cardiac arrhythmia requiring medication, or risk factors for polymorphic ventricular tachycardia
•Uncontrolled hypertension
•Left ventricular ejection fraction (LVEF) \<40%, as determined by screening echocardiogram (echocardiogram results obtained within 90 days prior to screening are acceptable)
•QT/QTc interval \>450 msec, as determined by screening electrocardiogram (ECG)
•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 joint inflammation or history of inflammatory arthritis or other immune disorder involving the joints
•Active infection requiring IV antibiotics within 2 weeks prior to screening
•Known history of hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis. Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease.

Outcomes

Primary Outcomes

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

Time Frame: 14 months

Secondary Outcomes

Number of participants experiencing dose limiting toxicity (DLT)(14 months)
Plasma pharmacokinetic parameters(28 days)
Number of participants experiencing related serious adverse events (SAEs) and/or adverse events (AEs)(14 months)
Levels of free active MIF and free total MIF in plasma and tumor tissue (where applicable)(14 months)
Number of serious adverse events (SAEs) and/or adverse events (AEs), regardless of causality(14 Months)
Number of participants who develop binding and/or neutralizing anti-anti-macrophage migration inhibitory factor (anti-MIF) antibodies following treatment with anti-MIF(14 months)
Tumor response(14 months)
Change in levels of tumor-associated biomarkers, if applicable based on cancer type, following treatment with anti-MIF antibody(14 months)
Number of related serious adverse events (SAEs) and/or adverse events (AEs)(14 months)
Number of dose limiting toxicities (DLTs)(14 months)
Anti-MIF antibody in tumor tissues, bound and/or unbound to active MIF (where applicable)(14 Months)
Levels of other potential biomarkers in tumor tissue (where applicable)(14 Months)