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Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors


Inclusion Criteria:



- Have solid organ tumors refractory to currently available treatments.

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

- Have a life expectancy of 4 months

- Have normal organ and bone marrow function

Exclusion Criteria:

- Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy
within 4 weeks prior to the 1st dose of the study drug or those who have not
recovered from adverse events from agents administered more than 4 weeks earlier.

- Use of investigational agent in the 4 weeks prior to 1st dose of the study drug

- Use of immunosuppressive therapy in the 4 weeks prior to the 1st dose

- Have a history of, or clinical evidence of, myocardial ischemia, congestive heart
failure, or myocardial arrhythmias requiring treatment within the past 6 months

- Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or
active infection such as hepatitis B or C, immune dysfunction such as autoimmune
disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness
such as depression or suicidal tendency or social situations that would limit
compliance with study requirements

- Have a history of disease requiring ongoing steroid treatment

- Have a history of seizure disorders uncontrolled on medication

- Have a history of clinically significant coagulation or bleeding disorders or
abnormalities

- Are HIV positive. HIV positive subjects are excluded from the study because of
possible interactions with the immunomodulatory effects of 852A and because of
potential pharmacokinetic interactions associated with combination retroviral
therapy.

- Are pregnant or lactating

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and Pharmacokinetics

Principal Investigator

Jeffrey Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2003LS039

NCT ID:

NCT00095160

Start Date:

October 2003

Completion Date:

January 2006

Related Keywords:

  • Neoplasms
  • Solid Organ Tumors
  • Neoplasms

Name

Location

University of MinnesotaMinneapolis, Minnesota  55455