Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
- Registration Number
- NCT00955786
- Lead Sponsor
- Cylene Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CX-3543 CX-3543 -
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) Cycle 1 Recommended Phase 2 dose Cycle 1
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) in humans of intravenously administered CX-3543. Monthly Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment. Every two months Pharmacodynamic evaluation of antitumor activity Monthly