Solid TumorsPhase 1NCT00033215
A Phase 1 Study of S-3304 in Patients With Solid Tumors
A Phase 1 study testing S-3304 in people with Solid Tumors, run by Shionogi at 4 sites in United States.
Trial summary
To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- S-3304
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2001to 12 Mar 2003
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven diagnosis of solid tumor(s) with biopsy accessible lesion(s)
- Must be able to tolerate oral medication Exclusion criteria
- Patients with other serious illnesses
- Patients who are receiving treatments
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Roswell Park Cancer Center
Buffalo, New York, 14263
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Colorado Hospital
Denver, Colorado, 80262
H. Lee Moffitt Concer Center and Research Institute
Tampa, Florida, 33612
About this study
To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population
- Conditions
- Solid Tumors
- Being tested
- S-3304
- Keywords
- neovascularization, matrix metalloproteinases, antiangiogenesis, type IV collagenases
- Medical subject headings
- Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-3304Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2002 (estimated)
- Study startNov 2001
- Primary completion13 Feb 2003
- Study completion12 Mar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Four dose levels were evaluated sequentially in separate groups of 6 to 8 patients: 1,600 mg/d (800 mg BID, Dose Level1 (DL1)), 3,200 mg/d (1,600 mg BID, DL2), 4,800 mg/d (2,400 mg BID, DL3), and 6,400 mg/d (3,200 mg BID, DL4). There was no intrapatient dose escalation.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033215
- Sponsor's protocol ID
- 0110P1416
- Status last verified
- Apr 2018
- First submitted
- 9 Apr 2002
- Last updated
- 26 Apr 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chiappori AA, Eckhardt SG, Bukowski R, Sullivan DM, Ikeda M, Yano Y, Yamada-Sawada T, Kambayashi Y, Tanaka K, Javle MM, Mekhail T, O'bryant CL, Creaven PJ. A phase I pharmacokinetic and pharmacodynamic study of s-3304, a novel matrix metalloproteinase inhibitor, in patients with advanced and refractory solid tumors. Clin Cancer Res. 2007 Apr 1;13(7):2091-9. doi: 10.1158/1078-0432.CCR-06-1586.
PubMed 17404091
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of S-3304 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00033215
- Acronym / sponsor ID
- 0110P1416
- Conditions
- Solid Tumors
- Keywords
- neovascularization, matrix metalloproteinases, antiangiogenesis, type IV collagenases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- Nov 2001 (actual)
- Primary completion
- 13 Feb 2003 (actual)
- Study completion
- 12 Mar 2003 (actual)
- First posted
- 10 Apr 2002 (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.
To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Model description
- Four dose levels were evaluated sequentially in separate groups of 6 to 8 patients: 1,600 mg/d (800 mg BID, Dose Level1 (DL1)), 3,200 mg/d (1,600 mg BID, DL2), 4,800 mg/d (2,400 mg BID, DL3), and 6,400 mg/d (3,200 mg BID, DL4). There was no intrapatient dose escalation.
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy proven diagnosis of solid tumor(s) with biopsy accessible lesion(s)
- Must be able to tolerate oral medication Exclusion criteria
- Patients with other serious illnesses
- Patients who are receiving treatments
Key exclusion criteria (0 listed)
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-3304 | 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 26 Apr 2018.
- Results publication: PubMed 17404091Chiappori AA, Eckhardt SG, Bukowski R, Sullivan DM, Ikeda M, Yano Y, Yamada-Sawada T, Kambayashi Y, Tanaka K, Javle MM, Mekhail T, O'bryant CL, Creaven PJ. A phase I pharmacokinetic and pharmacodynamic study of s-3304, a novel matrix metalloproteinase inhibitor, in patients with advanced and refractory solid tumors. Clin Cancer Res. 2007 Apr 1;13(7):2091-9. doi: 10.1158/1078-0432.CCR-06-1586.
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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.
4 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 S-3304 in people with Solid Tumors, run by Shionogi at 4 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 0 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 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00033215, which also lists 1 linked publication.
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 26 Apr 2018.