INNO-105 in Patients With Solid Tumors

Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00255333
• Other study ID #: INNO-105-901
• Status: Terminated
• Phase: Phase 1
• First received: November 16, 2005
• Last updated: May 11, 2007
• Start date: November 2005
• Est. completion date: March 2007

Study information

• Verified date: May 2007
• Source: Innovive Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• INNO-105

Locations

Country	Name	City	State
United States	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland
United States	Mary Crowley Medical Research Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Innovive Pharmaceuticals

Country where clinical trial is conducted

United States,