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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014