Back to resultsDose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
Primary Purpose
Advanced Solid Tumors, Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CX-3543
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumors focused on measuring Solid Tumors, Lymphoma, G-Quadruplex
Eligibility 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.
- A negative urine pregnancy test (if female.)
- Acceptable liver 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 not controlled by 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 a pulmonary compromise not correctable with therapy.
- 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 4 weeks 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 therapy.
- Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones), biological agent, or formulation.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CX-3543
Arm Description
Outcomes
Primary Outcome Measures
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)
Recommended Phase 2 dose
Secondary Outcome Measures
Pharmacokinetics (PK) in humans of intravenously administered CX-3543.
Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment.
Pharmacodynamic evaluation of antitumor activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00955786
Brief Title
Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
Official Title
A Phase I, Multicenter, Open-label, Dose-Escalation, Safety and Tolerance, and Pharmacokinetic Study of Intravenously Administered CX-3543,on a Daily x 5, Repeated Every 3 Weeks Schedule, in Patients With Advanced Solid Tumors or Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cylene Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.
Detailed Description
CX-4945 is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. This drug 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.This Phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Lymphoma
Keywords
Solid Tumors, Lymphoma, G-Quadruplex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CX-3543
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CX-3543
Other Intervention Name(s)
quarfloxacin, quarfloxin
Intervention Description
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)
Time Frame
Cycle 1
Title
Recommended Phase 2 dose
Time Frame
Cycle 1
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) in humans of intravenously administered CX-3543.
Time Frame
Monthly
Title
Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment.
Time Frame
Every two months
Title
Pharmacodynamic evaluation of antitumor activity
Time Frame
Monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
A negative urine pregnancy test (if female.)
Acceptable liver 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 not controlled by 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 a pulmonary compromise not correctable with therapy.
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 4 weeks 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 therapy.
Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones), biological agent, or formulation.
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
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