Clinical trial · Interventional
SU5416 in Treating Patients With Advanced Solid Tumors
A Phase I Pharmacodynamic Trial of SU5416 (NSC 696819)
NCT00005642CI-TRIAL-00003562completedPhase 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)
RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| semaxanib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors.
- timeFrame
- 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients followed every 3 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed solid tumors not amenable to conventional therapy At least 2 distinct lesions of metastatic or primary tumor of at least 1-2 cm OR Single lesion if large enough for both biopsy and MRI flow studies No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9.0 g/dL Hepatic: Bilirubin normal PT normal OR INR less than 1.1 PTT normal Renal: Creatinine less than 1.5 mg/dL AND/OR Creatinine clearance greater than 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease No uncompensated coronary artery disease on electrocardiogram or physical exam No myocardial infarction or severe or unstable angina within the past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep vein thrombosis or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy and recovered Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered Radiotherapy: At least 4 weeks since prior large field radiotherapy and recovered Surgery: Not specified
References
Publications (1)
- RESULTStopeck A, Sheldon M, Vahedian M, Cropp G, Gosalia R, Hannah A. Results of a Phase I dose-escalating study of the antiangiogenic agent, SU5416, in patients with advanced malignancies. Clin Cancer Res. 2002 Sep;8(9):2798-805. PMID 12231519