Lung CancerPhase 2NCT00080080
Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing talabostat (PT-100) tablets and Docetaxel in people with Lung Cancer, run by Point Therapeutics at 10 sites in United States.
Trial summary
The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- talabostat (PT-100) tablets and Docetaxel
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Start not givento not given
- 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 Stage IIIb/IV NSCLC
- Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
- Measurable disease
- ECOG Performance Status of 0 or 1
- Expected survival ≥12 weeks
- Provide written informed consent
Who cannot join
- More than 2 prior chemotherapy regimens
- Brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
- Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
- The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy
- A history of severe hypersensitivity reactions to drugs formulated with polysorbate 80
- A history of myocardial infarction within 1 year of study entry, CABG within 6 months of study entry, severe congestive heart failure (ejection fraction <30%), history of ventricular arrhythmia, or other uncontrolled cardiac arrhythmia
Show all 11Show fewer
- Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
- Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
- Pregnant or lactating women.
- Clinically significant laboratory abnormalities, specifically:
- Total bilirubin ≥institutional upper limit of normal (ULN); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN; Hepatitis B surface antigen or antibody to Hepatitis C (anti-HCV antibody); Serum creatinine ≥2.0mg/dL; or Granulocytes <1500/μL or platelets <100,000/μL.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
New York Oncology/Hematology--Albany Regional Cancer Center
Albany, New York, 12208
University of Chicago
Chicago, Illinois, 60637
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236
Dayton Oncology & Hematology
Kettering, Ohio, 45409
Mt. Sinai School of Medicine
New York, New York, 10029
USB Cancer Center-- Nyack Hospital
Nyack, New York, 10960
Cancer Center of Florida
Ocoee, Florida, 34761
Cancer Care Northwest
Spokane, Washington, 99218
Tyler Cancer Center
Tyler, Texas, 75702
About this study
Official title: Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.
- Conditions
- Lung Cancer
- Being tested
- talabostat (PT-100) tablets, Docetaxel
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talabostat (PT-100) tabletsDrug
DocetaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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)
Sponsor and investigators
- Lead sponsor
- Point Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080080
- Sponsor's protocol ID
- PTH-302
- Status last verified
- Jun 2007
- First submitted
- 23 Mar 2004
- Last updated
- 8 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00080080
- Acronym / sponsor ID
- PTH-302
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Point TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 24 Mar 2004 (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 purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.
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 (6 listed)
- Histologically or cytologically confirmed Stage IIIb/IV NSCLC
- Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
- Measurable disease
- ECOG Performance Status of 0 or 1
- Expected survival ≥12 weeks
Key exclusion criteria (11 listed)
- More than 2 prior chemotherapy regimens
- Brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
- Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
- The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy
- A history of severe hypersensitivity reactions to drugs formulated with polysorbate 80
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 |
|---|---|---|
| talabostat (PT-100) tablets | Drug | – |
| Docetaxel | Drug | – |
Primary outcome
Not reported in the source record.
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 8 Jun 2007.
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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.
10 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 talabostat (PT-100) tablets and Docetaxel in people with Lung Cancer, run by Point Therapeutics at 10 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 6 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 8 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
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 8 Jun 2007.