Title
INNO-105 in Patients With Solid Tumors
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
Phase
Phase 1Lead Sponsor
Innovive PharmaceuticalsStudy Type
InterventionalStatus
TerminatedIndication/Condition
TumorsIntervention/Treatment
inno-105 ...Study Participants
24The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.
Inclusion Criteria: 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 Criteria: 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).