NCT00073502

Brief Summary

Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2003

Geographic Reach
3 countries

11 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

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2003

Completed
Last Updated

February 22, 2006

Status Verified

October 1, 2003

First QC Date

November 21, 2003

Last Update Submit

February 17, 2006

Conditions

Gastroesophageal AdenocarcinomaGastric Adenocarcinoma

Interventions

OSI-7904LDRUG

Eligibility Criteria

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

You may qualify if:

  • Documented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No prior chemotherapy for locally advanced or metastatic disease Adequate baseline bone marrow, hepatic and renal function Age \>= 18 years At least one target lesion

You may not qualify if:

  • Active or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Dept Internal Medicine Gastrointestinal Oncology Unit

B-3000 Leuven, Belgium

Location

Bristol Haematology & Oncology Centre

Bristol, Avon, BS2 8ED, United Kingdom

Location

ICRF Medical Oncology Unit

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Deanesly Centre

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

NICCTU, East Podium, C-Floor

Belfast, BT9 7AB, United Kingdom

Location

Beatson Oncology Centre

Glasgow, G11 6NT, United Kingdom

Location

Cookridge Hospital

Leeds, LS16 6BB, United Kingdom

Location

Department of Medical Oncology

Manchester, M20 4BX, United Kingdom

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 acid

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2003

First Posted

November 25, 2003

Study Start

October 1, 2003

Study Completion

October 1, 2003

Last Updated

February 22, 2006

Record last verified: 2003-10

Locations

GB(7)US(3)BE(1)