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

NCT00955292 | Terminated Phase 1

• 1 other identifier: C3-07-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This phase 1 study of quarfloxin (CX-3543) is designed to test the safety, tolerability, and highest safe dose of this drug when administered intravenously weekly for three weeks of a four week cycle in patients with advanced solid tumors.

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 quarfloxin

  One month

• Evaluation of antitumor activity of quarfloxin by objective radiologic assessment

  Every 2 months

• Pharmacodynamic evaluation of antitumor activity

  Monthly

Study Arms (1)

Quarfloxin

EXPERIMENTAL

Drug: Quarfloxin

Interventions

Quarfloxin DRUG

Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks

Also known as: CX-3543, Quarfloxacin

Quarfloxin

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.
• Normal oxygen saturation by pulse oximetry on room air
• A negative pregnancy test (if female).
• Acceptable liver function as evaluated by laboratory results
• Acceptable renal 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 requiring 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 an uncorrectable pulmonary compromise.
• 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 one month 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 agent.
• 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, United States

Location

Unknown Facility

San Antonio, Texas, 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 7, 2009
• First Posted: August 10, 2009
• Study Start: July 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 10, 2009

Record last verified: 2009-08

Locations

US (2)