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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 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Lymphoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)

Outcome Time Frame:

Cycle 1

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

C3-05-001

NCT ID:

NCT00955786

Start Date:

July 2005

Completion Date:

December 2008

Related Keywords:

  • Advanced Solid Tumors
  • Lymphoma
  • Solid Tumors
  • Lymphoma
  • G-Quadruplex
  • Lymphoma
  • Neoplasms

Name

Location

Phoenix, Arizona  85012
Austin, Texas  78705