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

Sponsored by:	Cylene Pharmaceuticals
Information provided by:	Cylene Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00955292

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

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
Quarfloxin: Experimental	Drug: Quarfloxin Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks

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

Keywords provided by Cylene Pharmaceuticals:

Solid Tumors
Lymphoma
G-Quadruplex

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on September 11, 2009