Non Small Cell Lung CancerPhase 1/2NCT00078390
Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing S-3304 and Chemo-irradiation in people with Non Small Cell Lung Cancer and Lung Cancer, run by Shionogi at 5 sites in United States.
Trial summary
A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Lung Cancer, Stage IIIA Non Small Cell Lung Cancer
- What is being tested?
- S-3304 and Chemo-irradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2003to 26 Oct 2006
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion
- ECOG performance status 0-1
- adequate organ function
- clinically indicated and able to receive conventional chemoradiation therapy
Who cannot join
- patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment
- patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Cleveland Clinic
Cleveland, Ohio, 44195
VA Medical Center-East Orange (study available to veterans only)
East Orange, New Jersey, 07108
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Scripps Cancer Institute
La Jolla, California, 92037
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase I/II Study of the Safety, Pharmacokinetic Interaction and Efficacy of S-3304 in Combination With Standard Therapy in Patients With Locally Advanced Non-small Cell Lung Cancer.
A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.
Read the detailed description
A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer, Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non Small Cell Lung Cancer
- Being tested
- S-3304, Chemo-irradiation
- Keywords
- Lung cancer, Lung carcinoma, Non small cell lung cancer, Stage IIIA non small cell lung cancer, Stage IIIB non small cell lung cancer, NSCLC, Stage III, chemotherapy, radiation, chemoradiation, matrix metalloproteinases, neovascularization, antiangiogenesis, type IV collagenases, Unresectable locally advanced non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-3304Drug
S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
Chemo-irradiationOther
Standard of care chemo-irradiation
| Study group | Role | What they receive |
|---|---|---|
| S-3304 plus chemo-irradiation | Experimental | The tolerable dose of S-3304 determined in the Phase 1 part of the study will be dosed BID along with a standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy Receives: Drug: S-3304; Other: Chemo-irradiation |
| Chemo-irradiation | Active comparator | The standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered Receives: Other: Chemo-irradiation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2004 (estimated)
- Study startFeb 2003
- Primary completion28 Sep 2006
- Study completion26 Oct 2006
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.
- More trials run by ShionogiThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Phase 1 part of the study will determine the tolerable dose of S-3304 in the presence of radiation and paclitaxel/carboplatin chemotherapy in a non-randomized manner. The Phase 2 part will compare the effect combination of S-3304 in addition to chemo-irradiation therapy to the effect of radiation and paclitaxel/carboplatin chemotherapy alone on small cell lung tumors
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078390
- Sponsor's protocol ID
- 0207P1421
- Status last verified
- Apr 2018
- First submitted
- 24 Feb 2004
- Last updated
- 2 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of the Safety, Pharmacokinetic Interaction and Efficacy of S-3304 in Combination With Standard Therapy in Patients With Locally Advanced Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00078390
- Acronym / sponsor ID
- 0207P1421
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer, Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non Small Cell Lung Cancer
- Keywords
- Lung cancer, Lung carcinoma, Non small cell lung cancer, Stage IIIA non small cell lung cancer, Stage IIIB non small cell lung cancer, NSCLC, Stage III, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- Feb 2003 (actual)
- Primary completion
- 28 Sep 2006 (actual)
- Study completion
- 26 Oct 2006 (actual)
- First posted
- 26 Feb 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.
A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.
Detailed description
A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Phase 1 part of the study will determine the tolerable dose of S-3304 in the presence of radiation and paclitaxel/carboplatin chemotherapy in a non-randomized manner. The Phase 2 part will compare the effect combination of S-3304 in addition to chemo-irradiation therapy to the effect of radiation and paclitaxel/carboplatin chemotherapy alone on small cell lung tumors
| Arm | Type | Receives |
|---|---|---|
| S-3304 plus chemo-irradiation | Experimental | Drug: S-3304, Other: Chemo-irradiationThe tolerable dose of S-3304 determined in the Phase 1 part of the study will be dosed BID along with a standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy |
| Chemo-irradiation | Active comparator | Other: Chemo-irradiationThe standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion
- ECOG performance status 0-1
- adequate organ function
- clinically indicated and able to receive conventional chemoradiation therapy
Key exclusion criteria (2 listed)
- patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment
- patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment
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-3304S-3304 will be administered at the tolerable dose BID along with chemo-irradiation | Drug | S-3304 plus chemo-irradiation |
| Chemo-irradiationStandard of care chemo-irradiation | Other | Chemo-irradiation, S-3304 plus chemo-irradiation |
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 2 May 2018.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S-3304 and Chemo-irradiation in people with Non Small Cell Lung Cancer and Lung Cancer, run by Shionogi 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 2 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 2 May 2018. 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 combined 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.
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 2 May 2018.