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

NCT00955786 | Completed Phase 1

• 1 other identifier: C3-05-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumors; Lymphoma

Keywords

Solid Tumors; Lymphoma; G-Quadruplex

Outcome Measures

Primary Outcomes (2)

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

  Cycle 1

• Recommended Phase 2 dose

  Cycle 1

Secondary Outcomes (3)

• 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

Study Arms (1)

CX-3543

EXPERIMENTAL

Drug: CX-3543

Interventions

CX-3543 DRUG

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

Also known as: quarfloxacin, quarfloxin

CX-3543

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cylene Pharmaceuticals: lead

Study Sites (2)

Unknown Facility

Scottsdale, Arizona, 85259, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

CX 3543

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 10, 2009
• Study Start: July 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: December 1, 2008
• Last Updated: August 10, 2009

Record last verified: 2009-08

Locations

US (2)