INNO-105 in Patients With Solid Tumors

NCT ID: NCT00255333

Last Updated: 2007-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

INNO-105

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Innovive Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Casey Cunningham, MD

Role: PRINCIPAL_INVESTIGATOR

Mary Crowley Medical Research Center

Edward Sausville, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Greenebaum Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status

Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

INNO-105-901

Identifier Type: -

Identifier Source: org_study_id