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)
Information provided by:
First received: August 7, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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.
Advanced Solid Tumors
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2008 (Final data collection date for primary outcome measure)
Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|Scottsdale, Arizona, United States |
|San Antonio, Texas, United States |
No publications provided
||C. Padgett, Cylene Pharmaceuticals
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 7, 2009
||August 7, 2009
||United States: Food and Drug Administration
Keywords provided by Cylene Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Neoplasms by Histologic Type
Immune System Diseases