NCT00255333

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 14, 2007

Status Verified

May 1, 2007

First QC Date

November 16, 2005

Last Update Submit

May 11, 2007

Conditions

Tumors

Interventions

INNO-105DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Enkephalin, Methionine

Intervention Hierarchy (Ancestors)

EnkephalinsOpioid PeptidesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Casey Cunningham, MD

    Mary Crowley Medical Research Center

    PRINCIPAL INVESTIGATOR

  • Edward Sausville, M.D., Ph.D.

    University of Maryland Greenebaum Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 18, 2005

Study Start

November 1, 2005

Study Completion

March 1, 2007

Last Updated

May 14, 2007

Record last verified: 2007-05

Locations

US(2)