Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
This study has been completed.
Sponsor:
Cylene Pharmaceuticals
Information provided by:
Cylene Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00955786
First received: August 6, 2009
Last updated: August 7, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors Lymphoma |
Drug: CX-3543 |
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 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 |
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 CX-3543. [ Time Frame: Monthly ] [ Designated as safety issue: No ]
- Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment. [ Time Frame: Every two months ] [ Designated as safety issue: No ]
- Pharmacodynamic evaluation of antitumor activity [ Time Frame: Monthly ] [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | July 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CX-3543 |
Drug: CX-3543
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
Other Names:
|
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.
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.
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | C. Padgett, Cylene Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00955786 History of Changes |
| Other Study ID Numbers: | C3-05-001 |
| Study First Received: | August 6, 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 May 19, 2013