Advanced Solid TumorsPhase 1NCT00955786
Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
A Phase 1 study testing CX-3543 in people with Advanced Solid Tumors and Lymphoma, run by Cylene Pharmaceuticals at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Lymphoma
- What is being tested?
- CX-3543
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
San Antonio, Texas, 78229
Study site
Scottsdale, Arizona, 85259
About this study
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
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.
Read the 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.
- Conditions
- Advanced Solid Tumors, Lymphoma
- Being tested
- CX-3543
- Keywords
- Solid Tumors, Lymphoma, G-Quadruplex
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-3543Drug
Also called quarfloxacin, quarfloxin
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| CX-3543 | Experimental | Not described Receives: Drug: CX-3543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)
Measured: Cycle 1
Recommended Phase 2 dose
Measured: Cycle 1
Secondary outcomes (3)
Pharmacokinetics (PK) in humans of intravenously administered CX-3543.
Measured: Monthly
Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment.
Measured: Every two months
Pharmacodynamic evaluation of antitumor activity
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJul 2005
- Primary completionJul 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cylene Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955786
- Sponsor's protocol ID
- C3-05-001
- Status last verified
- Aug 2009
- First submitted
- 6 Aug 2009
- Last updated
- 10 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00955786
- Acronym / sponsor ID
- C3-05-001
- Conditions
- Advanced Solid Tumors, Lymphoma
- Keywords
- Solid Tumors, Lymphoma, G-Quadruplex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cylene PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CX-3543 | Experimental | Drug: CX-3543 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CX-3543Also: quarfloxacin, quarfloxinEscalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days. | Drug | CX-3543 |
Primary outcome
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)
Time frame: Cycle 1
Recommended Phase 2 dose
Time frame: Cycle 1
3 secondary outcomes
Pharmacokinetics (PK) in humans of intravenously administered CX-3543.
Time frame: Monthly
Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment.
Time frame: Every two months
Pharmacodynamic evaluation of antitumor activity
Time frame: Monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CX-3543 in people with Advanced Solid Tumors and Lymphoma, run by Cylene Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) (time frame: Cycle 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2009.