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

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

Study Overview

• Status: Terminated
• Conditions: Tumors
• Intervention / Treatment: Drug: INNO-105

• Study Type: Interventional
• Enrollment: 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Greenebaum Cancer Center
  • Texas
    • Dallas, Texas, United States, 75201
      • Mary Crowley Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Have a histologically or cytologically confirmed diagnosis of a solid malignancy (patients may have either measurable or nonmeasurable disease).
2. Be ≥18 years old.
3. Not eligible for effective therapy likely to provide clinical benefit.
4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
5. Acceptable pretreatment clinical laboratory results.
6. Life expectancy of greater than 12 weeks.

Exclusion Criteria:

1. Have received previous treatment with INNO-105.
2. Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
3. Are pregnant or lactating.
4. Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
5. Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.
6. Have not recovered from acute toxicity of all previous therapy prior to enrollment.
7. Have symptomatic or untreated central nervous system (CNS) metastases.
8. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Innovive Pharmaceuticals
• Investigators: Principal Investigator: Casey Cunningham, MD, Mary Crowley Medical Research Center; Principal Investigator: Edward Sausville, M.D., Ph.D., University of Maryland Greenebaum Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: November 16, 2005
• First Submitted That Met QC Criteria: November 17, 2005
• First Posted (Estimate): November 18, 2005

Study Record Updates

• Last Update Posted (Estimate): May 14, 2007
• Last Update Submitted That Met QC Criteria: May 11, 2007
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: INNO-105-901