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

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

Sponsors

Lead sponsor: Cylene Pharmaceuticals

Source 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.

Overall Status Completed
Start Date July 2005
Completion Date December 2008
Primary Completion Date July 2007
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) Cycle 1
Recommended Phase 2 dose Cycle 1
Secondary Outcome
Measure Time Frame
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
Enrollment 48
Condition
Intervention

Intervention type: Drug

Intervention name: CX-3543

Description: Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.

Arm group label: CX-3543

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
| Scottsdale, Arizona, 85259, United States
| San Antonio, Texas, 78229, United States
Location Countries

United States

Verification Date

August 2009

Responsible Party

Name title: C. Padgett

Organization: Cylene Pharmaceuticals

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: CX-3543

Arm group type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov