Clinical trial · Interventional
Dose-escalation Study of Quarfloxin in Patients With Advanced Solid Tumors or Lymphomas
A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Quarfloxin Administered Intravenously Weekly for Three Weeks of a Four Week Cycle in Patients With Advanced Solid Tumors or Lymphomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Modified dose schedule presented no advantage over previously studied schedule
Summary
Brief summary (as posted)
This phase 1 study of quarfloxin (CX-3543) is designed to test the safety, tolerability, and highest safe dose of this drug when administered intravenously weekly for three weeks of a four week cycle in patients with advanced solid tumors.
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 |
|---|---|---|---|
| Quarfloxin | Drug | Quarfloxin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Quarfloxin
- interventionNames
- Drug: Quarfloxin
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 quarfloxin
- timeFrame
- One month
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. * Normal oxygen saturation by pulse oximetry on room air * A negative pregnancy test (if female). * Acceptable liver function as evaluated by laboratory results * Acceptable renal 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 requiring 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 an uncorrectable pulmonary compromise. * 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 one month 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 agent. * 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