Clinical trial · Interventional
Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
A Phase I, Multicenter, Open-label, Dose-Escalation, Safety and Tolerance, and Pharmacokinetic Study of Intravenously Administered CX-3543,on a Daily x 5, Repeated Every 3 Weeks Schedule, in Patients With Advanced Solid Tumors or Lymphomas
NCT00955786CI-TRIAL-00002530completedPhase 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)
This phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CX-3543 | Drug | Quarfloxin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CX-3543
- interventionNames
- Drug: CX-3543
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)
- timeFrame
- Cycle 1
- measure
- Recommended Phase 2 dose
- timeFrame
- Cycle 1
Secondary outcomes (3)
- measure
- Pharmacokinetics (PK) in humans of intravenously administered CX-3543.
- timeFrame
- Monthly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed solid tumors or lymphomas. * Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy. * One or more tumors measurable on radiograph or CT scan, or evaluable disease. (e.g., malignant ascites) * Karnofsky performance status of greater than or equal to 70. * Life expectancy of at least 3 months. * Age at least 18 years. * Patients must have central IV access, or agree to the insertion of a central IV line. * A negative urine pregnancy test (if female.) * Acceptable liver function as evaluated by laboratory results * Acceptable hematologic status as evaluated by laboratory results * No clinically significant urinalysis abnormalities * Acceptable coagulation status as evaluated by laboratory results * Fertile men and women must use effective contraceptive methods during the study. Exclusion Criteria: * Seizure disorders not controlled by anticonvulsant therapy. * Known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months.) * Severe chronic obstructive pulmonary disease with hypoxemia or a pulmonary compromise not correctable with therapy. * Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug. * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. * Pregnant or nursing women. * Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C.) * Unwillingness or inability to comply with procedures required in this protocol. * Known infection with HIV, hepatitis B, or hepatitis C. * Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis. * Patients who are currently receiving any other investigational therapy. * Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones), biological agent, or formulation.
References
Publications (0)
Data not yet available
No reference posted for this study.