NCT00048529

SuspendedPhase 2

Study of T900607-Sodium in Subjects With Previously Treated ...

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Other study identifiers

Sponsor study identifier

T-607-006

Study Type

interventional

Reported enrollment (type unavailable)

70

Locations

1 country

Sites

5

Timeline

Study Start

September 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

Brief Summary

This is a clinical research study of T900607-sodium to determine if it is effective and safe in treating gastric cancer and adenocarcinoma of the esophagus. Patients will be treated on a weekly basis with an intravenous injection of the study drug.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: suspended
Reported enrollment (type unavailable): 70 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 5 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 1, 2002
Actual (reported)
First Posted
November 4, 2002
Actual (reported)

Last Updated: June 24, 2005
Status Verified: April 2004
Last Update Submitted: June 23, 2005

Conditions

Esophageal Neoplasms Gastric Cancer

Keywords

adenocarcinoma of the esophagus

Interventions

T900607-sodium intravenousDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically or cytologically confirmed diagnosis of gastric cancer or adenocarcinoma of the esophagus
Subjects must have received 1-2 regimens of prior chemotherapy

Sponsors & Collaborators

Tularik
Industrylead

Study Sites (5)

Pacific Oncology Associates

Los Gatos, California, 95032, United States

Scripps Health Center

San Diego, California, 92137, United States

Moffitt Cancer Center

Tampa, Florida, 33612, United States

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131, United States

Ireland Cancer Center

Cleveland, Ohio, 44106, United States

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal NeoplasmsAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Officials

Kerrie Boyd
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 1, 2002

First Posted

November 4, 2002

Study Start

September 2002

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

June 24, 2005

Record last verified: 2004-04

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Phase 2Terminated

At least 18 years of age

Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.

Karnofsky performance status of at least 70%

Estimated life expectancy of at least 12 weeks

Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive

Subject must be able to comply with study procedures and follow-up examinations.

Signed written informed consent

Lab Values (obtained ≤ 7 days prior to study enrollment):

ANC at least 1.5x10e9/L, \* Platelet count at least 100x10e9/L,

Creatinine within 2 times upper limit of normal \* AST and ALT within 5 times upper limit of normal

Bilirubin within 1.5 times upper limit of normal

Albumin great than 2.5 g/dL

You may not qualify if:

Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of \<50%, or acute anginal symptoms
Patients who have received any investigational agent within 4 weeks of enrollment
Patients who are pregnant or breast-feeding
History of prior malignancy other than gastric cancer or adenocarcinoma of the esophagus within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
History of central nervous system metastases or carcinomatous meningitis
Major surgery within 4 weeks of enrollment

Contact the study team to confirm eligibility.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00048529
Data provider: ClinicalTrials.gov
Source updated: 2005-06-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:25 UTC

Locations

US(5)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations