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

Daiichi Sankyo

Status and phase: Completed; Phase 1

Conditions: Sarcoma, Kaposi; HIV Infections

Treatments: Drug: Tecogalan sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002138

088D

4152A-PRT005

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.