Clinical trial · Interventional
A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days
NCT00002136CI-TRIAL-00000062completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| Sarcoma, Kaposi | Kaposi Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tecogalan sodium | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDEckhardt SG, et al. Results of a phase I trial of the novel angiogenesis inhibitor, tecogalan sodium (meeting abstract). Proc Annu Meet Am Assoc Cancer Res. 1995; 36:A628