Advanced Non-Small Cell Lung CancerPhase 2NCT00652561
Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing S-1 in people with Advanced Non-Small Cell Lung Cancer, run by Taiho Oncology, Inc..
Trial summary
The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-Small Cell Lung Cancer
- What is being tested?
- S-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to 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
- 1. Has given written informed consent. 2. Has histologically and/or cytologically proven unresectable or recurrent NSCLC stage IIIB with pleural effusion or pericardial effusion, or stage IV (mixed forms with small cell lung cancer are excluded).
- 3. Has received prior 1st line chemotherapy combination (platinum or non-platinum-based) treatment and has not received any 2nd line therapy.
- 4. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, ie, has at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral Computed Tomography (CT) scan.
- 5. Is able to take medications orally. 6. Is ≥ 18 years of age. 7. Has an ECOG performance status 0 or 1. 8. Has adequate organ function as defined by the following criteria:
- AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis AST (SGOT) and ALT (SGPT) ≤ 5 x ULN.
- Total serum bilirubin of ≤ 1.5 x ULN.
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- Absolute granulocyte count of ≥ 1,500/mm3.
- Platelet count ≥ 100,000/mm3.
- Hemoglobin of ≥ 9.0 g/dL.
- Calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula). 9. Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- 1. Has had treatment with any of the following within the specified time frame prior to study drug administration:
- Any investigational agent either concurrently or within the past 30 days.
- Any prior 1st line treatment with S-1 for NSCLC.
- Previous therapy for NSCLC within the past 21 days, including any chemotherapy, immunotherapy, biologic or hormonal therapy (6 weeks for nitrosureas or mitomycin C).
- Radiotherapy within the prior 2 weeks.
- Any radiation therapy to a target lesion within the past 3 months, unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease).
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- Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study.
- 2. Has a serious illness or medical condition(s) including, but not limited to, the following:
- <!-- -->
- Other active malignancies.
- Symptomatic brain metastasis not controlled by corticosteroids.
- Leptomeningeal metastasis.
- Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV.
- Chronic nausea, vomiting, and/or diarrhea.
- Psychiatric disorder that may interfere with consent and/or protocol compliance.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
- 3. Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
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- Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity).
- Allopurinol (may diminish S-1 activity).
- Phenytoin (S-1 may enhance phenytoin activity).
- Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity).
- 4. Is a pregnant or lactating female. 5. With reproductive potential and refuses to use an adequate means of contraception (including male patients).
About this study
Official title: An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2nd Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1.
Read the detailed description
Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione [FT]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine [CDHP]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the efficacy and safety of single agent S-1 as 2nd line therapy for patients with advanced NSCLC. The 3 stages of this study correspond to a futility stage (stage 1), a decision stage (stage 2), and a stage for improvement of precision of ORR (stage 3).
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Being tested
- S-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the second stage only if the stage 2 criteria are met, where 3/30 (10%) or more patients must have achieved a confirmed response (CR or PR) in stage 1.The study may go to the third stage only if at least 8/50 patients (16%) must have achieved a confirmed response in stage 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR)
Measured: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Tumor assessmentswill be obtained at baseline and at the end of every even cycle
Secondary outcomes (3)
To evaluate the duration of response (DR), and progression-free survival (PFS)
Measured: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Pts will be followed for survival every 2 mos after PD for up to 12 mos from the date of enrollment of the last pt.
To evaluate the safety profile of S-1
Measured: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death/removal from study. AEs reported through f/up; blood/urine collected at baseline, Days 8&15, w/in 24 hrs of drug on Day 1 of each cycle after Cycle 1, at end of treatment.
To investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters
Measured: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. s Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startFeb 2005
- 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 Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., United BioSource, LLC
- Investigators
- Fabio Benedetti, MD, Study director, Taiho Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652561
- Sponsor's protocol ID
- TPU-S1203
- Status last verified
- Aug 2024
- First submitted
- 31 Mar 2008
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2nd Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
- ClinicalTrials.gov ID
- NCT00652561
- Acronym / sponsor ID
- TPU-S1203
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., United BioSource, LLC
- Study start
- Feb 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 3 Apr 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.
The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1.
Detailed description
Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione [FT]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine [CDHP]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the efficacy and safety of single agent S-1 as 2nd line therapy for patients with advanced NSCLC. The 3 stages of this study correspond to a futility stage (stage 1), a decision stage (stage 2), and a stage for improvement of precision of ORR (stage 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-1All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Has given written informed consent. 2. Has histologically and/or cytologically proven unresectable or recurrent NSCLC stage IIIB with pleural effusion or pericardial effusion, or stage IV (mixed forms with small cell lung cancer are excluded).
- 3. Has received prior 1st line chemotherapy combination (platinum or non-platinum-based) treatment and has not received any 2nd line therapy.
- 4. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, ie, has at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral Computed Tomography (CT) scan.
- 5. Is able to take medications orally. 6. Is ≥ 18 years of age. 7. Has an ECOG performance status 0 or 1. 8. Has adequate organ function as defined by the following criteria:
Key exclusion criteria (24 listed)
- 1. Has had treatment with any of the following within the specified time frame prior to study drug administration:
- 2. Has a serious illness or medical condition(s) including, but not limited to, the following:
- <!-- -->
- 3. Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
- <!-- -->
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 |
|---|---|---|
| S-1All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the second stage only if the stage 2 criteria are met, where 3/30 (10%) or more patients must have achieved a confirmed response (CR or PR) in stage 1.The study may go to the third stage only if at least 8/50 patients (16%) must have achieved a confirmed response in stage 2 | Drug | 1 |
Primary outcome
Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR)
Time frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Tumor assessmentswill be obtained at baseline and at the end of every even cycle
3 secondary outcomes
To evaluate the duration of response (DR), and progression-free survival (PFS)
Time frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Pts will be followed for survival every 2 mos after PD for up to 12 mos from the date of enrollment of the last pt.
To evaluate the safety profile of S-1
Time frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death/removal from study. AEs reported through f/up; blood/urine collected at baseline, Days 8&15, w/in 24 hrs of drug on Day 1 of each cycle after Cycle 1, at end of treatment.
To investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters
Time frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. s Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only.
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 3 Sep 2024.
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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.
Fabio Benedetti, MD study director
Taiho Oncology, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 in people with Advanced Non-Small Cell Lung Cancer, run by Taiho Oncology, Inc..
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 10 inclusion and 24 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 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR) (time frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Tumor assessmentswill be obtained at baseline and at the end of every even cycle). 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 3 Sep 2024.