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 1
  • Study Type

    Interventional
  • Status

    Terminated
  • Intervention/Treatment

    inno-105 ...
  • Study Participants

    24
The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.
Study Started
Nov 30
2005
Study Completion
Mar 31
2007
Last Update
May 14
2007
Estimate

Drug INNO-105

Criteria

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).
No Results Posted