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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955786
• Other study ID #: C3-05-001
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2009
• Last updated: August 7, 2009
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Cylene Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cylene Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)		Cycle 1	Yes
Primary	Recommended Phase 2 dose		Cycle 1	Yes
Secondary	Pharmacokinetics (PK) in humans of intravenously administered CX-3543.		Monthly	No
Secondary	Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment.		Every two months	No
Secondary	Pharmacodynamic evaluation of antitumor activity		Monthly	No