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

This study has been terminated.
(Modified dose schedule presented no advantage over previously studied schedule)
Sponsor:
Information provided by:
Cylene Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00955292
First received: August 7, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Lymphoma
Drug: Quarfloxin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Quarfloxin Administered Intravenously Weekly for Three Weeks of a Four Week Cycle in Patients With Advanced Solid Tumors or Lymphomas

Resource links provided by NLM:


Further study details as provided by Cylene Pharmaceuticals:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
  • Recommended Phase 2 dose [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK) in humans of intravenously administered quarfloxin [ Time Frame: One month ] [ Designated as safety issue: No ]
  • Evaluation of antitumor activity of quarfloxin by objective radiologic assessment [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
  • Pharmacodynamic evaluation of antitumor activity [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quarfloxin Drug: Quarfloxin
Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks
Other Names:
  • CX-3543
  • Quarfloxacin

Detailed Description:

Quarfloxin is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. Quarfloxin 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955292

Locations
United States, Arizona
Scottsdale, Arizona, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Cylene Pharmaceuticals
  More Information

No publications provided

Responsible Party: C. Padgett, Cylene Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00955292     History of Changes
Other Study ID Numbers: C3-07-002
Study First Received: August 7, 2009
Last Updated: August 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Cylene Pharmaceuticals:
Solid Tumors
Lymphoma
G-Quadruplex

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014