INNO-105 in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255333
Recruitment Status : Terminated (Development of this compound was discontinued.)
First Posted : November 18, 2005
Last Update Posted : May 14, 2007
Information provided by:
Innovive Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Tumors Drug: INNO-105 Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Study Completion Date : March 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255333

United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201
Sponsors and Collaborators
Innovive Pharmaceuticals
Principal Investigator: Casey Cunningham, MD Mary Crowley Medical Research Center
Principal Investigator: Edward Sausville, M.D., Ph.D. University of Maryland Greenebaum Cancer Center Identifier: NCT00255333     History of Changes
Other Study ID Numbers: INNO-105-901
First Posted: November 18, 2005    Key Record Dates
Last Update Posted: May 14, 2007
Last Verified: May 2007