Title
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
Phase
Phase 1Lead Sponsor
Cylene PharmaceuticalsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Advanced Solid Tumors LymphomaIntervention/Treatment
quarfloxin ...Study Participants
48This 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.
CX-4945 is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. This drug was rationally designed to target a G-quadruplex (QPLX) DNA structure and disrupt protein-DNA interactions essential to cancer cells. The QPLX targeted by quarfloxin forms within ribosomal DNA (rDNA) and the QPLX is bound by the nucleolin protein.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.
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
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.
