Expired Study
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New York, New York 10021


Purpose:

To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.


Study summary:

Patients receive intravenous DS-4152 by infusion twice weekly for 21 days, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.


Criteria:

Inclusion Criteria Patients must have: - Kaposi's sarcoma plus HIV infection OR metastatic solid tumor. - Life expectancy of at least 12 weeks. - NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks. - Recovered from toxicity of any prior anticancer therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Leukemia or lymphoma. - Current gastrointestinal bleeding by stool guaiac. - Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors. - Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics. - Acute intercurrent infection other than genital herpes. - Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy. Concurrent Medication: Excluded: - Other anticancer therapy. - Other investigational agents. Patients with the following prior conditions are excluded: - History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease. - History of myocardial infarction within past 6 months. Prior Medication: Excluded: - Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C). - Investigational agents within the past 4 weeks.


Study is Available At:


Original ID:

088C


NCT ID:

NCT00002342


Secondary ID:

4152A-PRT004


Study Acronym:


Brief Title:

A Study of Tecogalan Sodium


Official Title:

A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Twice Weekly for 21 Days


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:April 1996
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Tecogalan sodium

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Daiichi Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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