A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Weekly Intravenous INNO-105 in Adult Patients With Advanced Solid Malignancies

Innovive Pharmaceuticals4 sites in 1 country24 target enrollmentStarted: November 1, 2005Last updated: May 14, 2007

Conditions

Drugs

Trial Snapshot

The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.

•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 ≤
•Acceptable pretreatment clinical laboratory results.
•Life expectancy of greater than 12 weeks.

•Have received previous treatment with INNO-
•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).

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