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Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00955786•Cylene Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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.
+2 more criteria

Locations (2)

Scottsdale, Arizona, United States

San Antonio, Texas, United States

Key Dates

Start Date

July 1, 2005

Primary Completion Date

July 1, 2007

Completion Date

December 1, 2008

Last Updated

August 10, 2009

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorsLymphoma

Interventions

CX-3543

DRUG

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

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RECRUITINGPHASE2

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

NCT06263491

Mantle Cell Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 10, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma