Status:
TERMINATED
INNO-105 in Patients With Solid Tumors
Lead Sponsor:
Innovive Pharmaceuticals
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.
Eligibility Criteria
Inclusion
- Have a histologically or cytologically confirmed diagnosis of a solid malignancy (patients may have either measurable or nonmeasurable disease).
- Be ≥18 years old.
- Not eligible for effective therapy likely to provide clinical benefit.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Acceptable pretreatment clinical laboratory results.
- Life expectancy of greater than 12 weeks.
Exclusion
- Have received previous treatment with INNO-105.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- Are pregnant or lactating.
- Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.
- Have not recovered from acute toxicity of all previous therapy prior to enrollment.
- Have symptomatic or untreated central nervous system (CNS) metastases.
- Have a susceptibility to hypotension, bradycardia, and/or hypopnea, such as patients with known coronary heart disease, arrhythmias, cerebral vascular disease, and chronic obstructive airways disease (CO2-retaining).
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00255333
Start Date
November 1 2005
End Date
March 1 2007
Last Update
May 14 2007
Active Locations (2)
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1
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
2
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201