Carcinoma, Small Cell LungPhase 2NCT00435578
Safety and Efficacy Study of Glufosfamide in Patients With Recurrent Sensitive Small Cell Lung Carcinoma
A Phase 2 study testing Glufosfamide in people with Carcinoma, Small Cell Lung, run by Threshold Pharmaceuticals at 3 sites in United States.
Trial summary
The primary objectives of this study are: 1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer (SCLC) as measured by objective response rate 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Small Cell Lung
- What is being tested?
- Glufosfamide
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Nov 2007
- 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
- At least 18 years of age
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/IEC
- Documented extensive SCLC with progression occurring at least 60 days after completion of first-line therapy (sensitive disease)
- Measurable disease by RECIST criteria (at least one target lesion; no target lesion may have received radiotherapy within 6 weeks of study start)
- A minimum of 21 days between prior radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
- Recovered from reversible toxicities of prior therapy
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- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1,500/µL, platelets ≥ 100,000/µL
- Total bilirubin ≤ 1.5-fold ULN
- AST/ALT ≤ 2.5-fold ULN (≤ 5-fold ULN if liver metastases)
- Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula)
- All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose
Who cannot join
- More than one previous chemotherapy regimen
- Concomitant or planned hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for SCLC other than protocol therapy
- Limited stage SCLC (defined as confined to one hemithorax including ipsilateral supraclavicular lymph nodes and excluding pleural effusion)
- Symptomatic brain metastases requiring corticosteroids
- Active clinically significant infection requiring antibiotics
- Known HIV positive or active hepatitis B or C
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- Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, congestive heart failure, or stroke
- Other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
- Major surgery within 28 days of the start of study treatment, without complete recovery
- Females who are pregnant or breast-feeding
- Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
- Concomitant disease or condition that could interfere with the conduct of the study, or that, in the opinion of the investigator, could pose an unacceptable risk to the subject in this study.
- Unwillingness or inability to comply with the study protocol for any other reason
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
California Cancer Center
Greenbrae, California, 94904
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Glufosfamide in the Treatment of Patients With Recurrent Sensitive Small Cell Lung Carcinoma
The primary objectives of this study are:
- To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer (SCLC) as measured by objective response rate
- To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC
Read more
The secondary objectives are:
- To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response, progression-free survival and overall survival
- To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM)
The exploratory objectives of this trial are:
- To evaluate the effect of glufosfamide on lung cancer symptoms
- To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide
- Conditions
- Carcinoma, Small Cell Lung
- Being tested
- Glufosfamide
- Keywords
- Recurrent Sensitive Small-Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlufosfamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Small Cell LungStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Threshold Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerold Bepler, MD, PhD, Principal investigator, H. Lee Moffitt Cancer Center and Research InstituteJohn C Ruckdeschel, MD, Principal investigator, Barbara Ann Karmanos Cancer InstitutePeter D Eisenberg, MD, Principal investigator, California Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435578
- Sponsor's protocol ID
- TH-CR-304
- Status last verified
- Apr 2009
- First submitted
- 13 Feb 2007
- Last updated
- 30 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Glufosfamide in the Treatment of Patients With Recurrent Sensitive Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT00435578
- Acronym / sponsor ID
- TH-CR-304
- Conditions
- Carcinoma, Small Cell Lung
- Keywords
- Recurrent Sensitive Small-Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Threshold PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Feb 2007 (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.
The primary objectives of this study are:
- To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer (SCLC) as measured by objective response rate
- To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC
The secondary objectives are:
- To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response, progression-free survival and overall survival
- To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM)
The exploratory objectives of this trial are:
- To evaluate the effect of glufosfamide on lung cancer symptoms
- To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 18 years of age
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/IEC
- Documented extensive SCLC with progression occurring at least 60 days after completion of first-line therapy (sensitive disease)
- Measurable disease by RECIST criteria (at least one target lesion; no target lesion may have received radiotherapy within 6 weeks of study start)
- A minimum of 21 days between prior radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
Key exclusion criteria (13 listed)
- More than one previous chemotherapy regimen
- Concomitant or planned hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for SCLC other than protocol therapy
- Limited stage SCLC (defined as confined to one hemithorax including ipsilateral supraclavicular lymph nodes and excluding pleural effusion)
- Symptomatic brain metastases requiring corticosteroids
- Active clinically significant infection requiring antibiotics
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 |
|---|---|---|
| Glufosfamide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 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.
Gerold Bepler, MD, PhD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
John C Ruckdeschel, MD principal investigator
Barbara Ann Karmanos Cancer Institute
Peter D Eisenberg, MD principal investigator
California Cancer Center
3 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 Glufosfamide in people with Carcinoma, Small Cell Lung, run by Threshold Pharmaceuticals at 3 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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 30 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early. Results are not available in the source record.
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.
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 30 Apr 2009.