A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days
Completed · Phase 1
Conditions studied: Sarcoma, Kaposi, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002136
- Run by
- Daiichi Pharmaceuticals
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cancer Therapy Research Ctr — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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