Clinical trial · Interventional
Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors
PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 (ET-743) ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with 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 |
|---|---|---|---|
| trabectedin | Drug | Trabectedin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy No evidence of brain involvement or leptomeningeal disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: ANC at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL Transaminases normal (no greater than 2.5 times normal if liver metastases) Alkaline phosphatase normal (no greater than 2.5 times normal if liver or bone metastases) No history of chronic liver disease, e.g., chronic active hepatitis, cirrhosis Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Other: No active bacterial infection (e.g., abscess) or with fistulae No grade 2 or worse neurotoxicity No concurrent medical condition that precludes treatment No history of alcoholism, drug addiction, or psychotic disorder Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Colony-stimulating factors allowed for specific indications At least 4 weeks since prior biologic therapy, immunotherapy, or growth factors Chemotherapy: No prior intensive chemotherapy with bone marrow or stem cell support At least 4 weeks since chemotherapy (6 weeks since nitrosoureas, mitomycin, or high-dose carboplatin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Concomitant palliative local radiotherapy allowed for existing lesion Surgery: Recovered from prior surgery Other: No concurrent investigational drug Concurrent prophylactic antiemetics allowed after first therapy course
References
Publications (0)
Data not yet available