Neuroendocrine TumorsPhase 2NCT00780663
Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
A Phase 2 study testing Quarfloxin in people with Neuroendocrine Tumors and Carcinoid Tumor, run by Cylene Pharmaceuticals at 13 sites in United States.
Trial summary
This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Carcinoid Tumor
- What is being tested?
- Quarfloxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 2008to Mar 2010
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma including carcinoid and islet cell cancer. Patients with neuroendocrine tumors associated with MEN1 syndrome are eligible.
- Measureable disease by RECIST
- Unresectable or metastatic disease
- Secretory symptoms of diarrhea or flushing or both attributed to their carcinoid tumor and/or quantifiable hormones or other biochemical markers
- Males and females 18 years of age or older.
- Zero to two prior cytotoxic chemotherapy regimens.
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- Patients may be receiving concomitant octreotide Sandostatin®
- Patients must have central IV access, or agree to the insertion of a central IV line.
- All previous cancer therapies, radiation, and surgery, must have been discontinued at least 21 days prior to the start of treatment.
- Acceptable liver function
- Acceptable renal function
- Acceptable hematologic status
- ECOG Performance Status ≤1.
- Anticipated survival of at least 6 months.
- Able to maintain a patient diary.
- For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
- Ability to understand the requirements of the study, provide written informed consent and agree to abide by the study restrictions and return to the clinic for required assessments.
Who cannot join
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid or small cell carcinoma.
- Pregnant or nursing women.
- Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
- Seizures not controlled by anticonvulsant therapy.
- Participation in any investigational drug study within 28 days before quarfloxin administration or currently receiving investigational therapy.
- Patients with a second malignancy requiring active treatment.
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- Active symptomatic bacterial, fungal, or viral infection including active HIV or viral hepatitis.
- Prior treatment with quarfloxin.
- 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 have exhibited allergic reactions to a similar structural compound or formulation.
- Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Texas Oncology
Amarillo, Texas
Birmingham Hematology and Oncology
Birmingham, Alabama
Texas Oncology
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
El Paso Cancer Treatment Center
El Paso, Texas
Front Range Cancer Specialists
Fort Collins, Colorado
Cancer Care Centers of South Texas
Kerrville, Texas
Southern New Mexico Cancer Center
Las Cruces, New Mexico
Study site
Ocala, Florida, 34471
UT Health Science Center
San Antonio, Texas, 78229
Virginia Mason Medical Center
Seattle, Washington, 98101
Tyler Cancer Center
Tyler, Texas, 75702
Northwest Cancer Specialists
Vancouver, Washington, 98684
About this study
Official title: A Phase 2, Multi-Center, Open Label Study Evaluating the Efficacy and Safety of Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable hormones or other biochemical tumor markers.
- Conditions
- Neuroendocrine Tumors, Carcinoid Tumor
- Being tested
- Quarfloxin
- Keywords
- Neuroendocrine, Carcinoid, NET, MEN-1, Islet cell
- Medical subject headings
- Neuroendocrine Tumors, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuarfloxinDrug
Also called CX-3543
IV Quarfloxin 240 mg/m2 daily x5 days every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Quarfloxin | Experimental | Single arm study - open label. Receives: Drug: Quarfloxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit. Clinical benefit is defined as a reduction of secretory symptoms or reduction of quantifiable hormones or other biochemical tumor markers where concomitantly there is an absence of radiological evidence for tumor progression.
Measured: monthly for clinical benefit, every two months for tumor progression
Secondary outcomes (1)
Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cylene Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780663
- Sponsor's protocol ID
- C3-07-003
- Status last verified
- Jun 2011
- First submitted
- 27 Oct 2008
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Open Label Study Evaluating the Efficacy and Safety of Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT00780663
- Acronym / sponsor ID
- C3-07-003
- Conditions
- Neuroendocrine Tumors, Carcinoid Tumor
- Keywords
- Neuroendocrine, Carcinoid, NET, MEN-1, Islet cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cylene PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Oct 2008 (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 is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable hormones or other biochemical tumor markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quarfloxin | Experimental | Drug: QuarfloxinSingle arm study - open label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma including carcinoid and islet cell cancer. Patients with neuroendocrine tumors associated with MEN1 syndrome are eligible.
- Measureable disease by RECIST
- Unresectable or metastatic disease
- Secretory symptoms of diarrhea or flushing or both attributed to their carcinoid tumor and/or quantifiable hormones or other biochemical markers
- Males and females 18 years of age or older.
Key exclusion criteria (11 listed)
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid or small cell carcinoma.
- Pregnant or nursing women.
- Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
- Seizures not controlled by anticonvulsant therapy.
- Participation in any investigational drug study within 28 days before quarfloxin administration or currently receiving investigational 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 |
|---|---|---|
| QuarfloxinAlso: CX-3543IV Quarfloxin 240 mg/m2 daily x5 days every 21 days | Drug | Quarfloxin |
Primary outcome
Clinical benefit. Clinical benefit is defined as a reduction of secretory symptoms or reduction of quantifiable hormones or other biochemical tumor markers where concomitantly there is an absence of radiological evidence for tumor progression.
Time frame: monthly for clinical benefit, every two months for tumor progression
1 secondary outcome
Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin.
Time frame: One year
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 15 Jun 2011.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quarfloxin in people with Neuroendocrine Tumors and Carcinoid Tumor, run by Cylene Pharmaceuticals at 13 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 17 inclusion and 11 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 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinical benefit. Clinical benefit is defined as a reduction of secretory symptoms or reduction of quantifiable hormones or other biochemical tumor markers where concomitantly there is an absence of radiological evidence for tumor progression. (time frame: monthly for clinical benefit, every two months for tumor progression). 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 15 Jun 2011.