INNO-105 in Patients With Solid Tumors

This study has been terminated.
(Development of this compound was discontinued.)
Sponsor:
Information provided by:
Innovive Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00255333
First received: November 16, 2005
Last updated: May 11, 2007
Last verified: May 2007
  Purpose

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


Condition Intervention Phase
Tumors
Drug: INNO-105
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Innovive Pharmaceuticals:

Estimated Enrollment: 24
Study Start Date: November 2005
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255333

Locations
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
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00255333     History of Changes
Other Study ID Numbers: INNO-105-901
Study First Received: November 16, 2005
Last Updated: May 11, 2007
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 29, 2014