Non-small Cell Lung CancerPhase 1NCT00569114
Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients
A Phase 1 study testing TG01 in people with Non-small Cell Lung Cancer, run by Tragara Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- TG01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2007to Nov 2009
- 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
- Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC.
- Measurable or evaluable disease as defined by RECIST
- Must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
- ECOG perfromance status of 0,1, or 2.
Who cannot join
- Radiation therapy (excluding CNS therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
- Evidence of New York Heart Associatation Class III or greater cardiac disease.
- History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
- Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin.
- Systemic central nervous system metastases. The patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week.
- Pregnant or nursing women.
- Patients who are primarily refactory to erlotinib.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Comprehensive Blood and Cancer Center
Bakersfield, California
City of Hope
Duarte, California
Nevada Cancer Institute
Las Vegas, Nevada
University of Southern California
Los Angeles, California
University of California at Davis
Sacramento, California
About this study
Official title: A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- TG01
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG01Drug
Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: TG01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
Measured: Baseline, 8, 15 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell 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 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tragara Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sara Zaknoen, MD, Study director, Tragara Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569114
- Sponsor's protocol ID
- TP2001-101
- Status last verified
- Mar 2010
- First submitted
- 4 Dec 2007
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00569114
- Acronym / sponsor ID
- TP2001-101
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tragara Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Dec 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.
This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: TG01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC.
- Measurable or evaluable disease as defined by RECIST
- Must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
- ECOG perfromance status of 0,1, or 2.
Key exclusion criteria (7 listed)
- Radiation therapy (excluding CNS therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
- Evidence of New York Heart Associatation Class III or greater cardiac disease.
- History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
- Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin.
- Systemic central nervous system metastases. The patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week.
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 |
|---|---|---|
| TG01Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD | Drug | 1 |
Primary outcome
Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
Time frame: Baseline, 8, 15 and 28 days
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 17 Mar 2010.
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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.
Sara Zaknoen, MD study director
Tragara Pharmaceuticals
5 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 TG01 in people with Non-small Cell Lung Cancer, run by Tragara Pharmaceuticals, Inc. at 5 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 4 inclusion and 7 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 17 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics. (time frame: Baseline, 8, 15 and 28 days). 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 17 Mar 2010.