NCT00116896

Brief Summary

This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

2 active sites

Status
completed

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

June 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2005

Completed
Last Updated

January 21, 2009

Status Verified

November 1, 2003

First QC Date

June 30, 2005

Last Update Submit

January 16, 2009

Conditions

Advanced Solid Tumors

Interventions

OSI-7904LDRUG
CisplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Advanced and/or metastatic solid tumor for which no effective therapy is available
  • ECOG performance status 0-2
  • Adequate bone marrow, hepatic and renal function

You may not qualify if:

  • Patients with active or uncontrolled infections
  • Neurotoxicity \>= Grade 2
  • Symptomatic brain metastases which are not stable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt Universtiy Medical Center

Nashville, Tennessee, 37232-6307, United States

Location

Institute for Drug DevelopmentCancer Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

((S)-2-(5-(1,2-dihydro-3-methyl-1-oxobenzo(f)-quinazoline-9-yl)methyl)amino-1-oxo-2-isoindolynyl)-glutaric acidCisplatin

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 1, 2005

Study Start

June 1, 2003

Study Completion

December 1, 2004

Last Updated

January 21, 2009

Record last verified: 2003-11

Locations

US(2)