TumorsPhase 1NCT00195325
Study Evaluating TTI-237 in Advanced Malignant Solid Tumors.
A Phase 1 study testing TTI-237 in people with Tumors and Neoplasms, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and MTD (maximum tolerated dose) of TTI-237 for the treatment of subjects with advanced malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- TTI-237
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2005to not given
- 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
- Documented diagnosis of malignant solid tumor with measurable disease
- Life expectancy of at least 12 weeks
- ECOG (The Eastern Cooperative Oncology Group scale) performance status of 0, 1, or 2
Who cannot join
- Recent major surgery, radiation therapy or anti-cancer treatment
- History of any other prior malignancy within the last 5 years
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Cleveland, Ohio, 44195
Study site
Lexington, Kentucky, 40536-0098
Study site
Nashville, Tennessee, 37232-6307
About this study
Official title: A Phase 1 Dose Escalation Study of TTI-237 Administered Intravenously (IV) Once Weekly in Subjects With Advanced Malignant Solid Tumors.
The purpose of this study is to evaluate the safety, tolerability, and MTD (maximum tolerated dose) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.
- Being tested
- TTI-237
- Keywords
- Advanced Malignant Solid Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTI-237Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine safety, tolerability, and MTD of TTI-237 - patients are monitored during the duration of their participation on the trial.
Secondary outcomes (1)
Preliminary pharmacokinetics (during cycle 1) and anti-tumor activity of TTI-237 (approximately every 8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195325
- Sponsor's protocol ID
- 3162K1-100
- Status last verified
- Mar 2007
- First submitted
- 12 Sep 2005
- Last updated
- 26 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of TTI-237 Administered Intravenously (IV) Once Weekly in Subjects With Advanced Malignant Solid Tumors.
- ClinicalTrials.gov ID
- NCT00195325
- Acronym / sponsor ID
- 3162K1-100
- Keywords
- Advanced Malignant Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 19 Sep 2005 (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 evaluate the safety, tolerability, and MTD (maximum tolerated dose) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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 (3 listed)
- Documented diagnosis of malignant solid tumor with measurable disease
- Life expectancy of at least 12 weeks
- ECOG (The Eastern Cooperative Oncology Group scale) performance status of 0, 1, or 2
Key exclusion criteria (2 listed)
- Recent major surgery, radiation therapy or anti-cancer treatment
- History of any other prior malignancy within the last 5 years
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 |
|---|---|---|
| TTI-237 | Drug | – |
Primary outcome
To determine safety, tolerability, and MTD of TTI-237 - patients are monitored during the duration of their participation on the trial.
1 secondary outcome
Preliminary pharmacokinetics (during cycle 1) and anti-tumor activity of TTI-237 (approximately every 8 weeks).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
3 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 TTI-237 in people with Tumors and Neoplasms, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 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 3 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: stopped early, as of the sponsor's last update on 26 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early. Results are not available in the source record.
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?
To determine safety, tolerability, and MTD of TTI-237 - patients are monitored during the duration of their participation on the trial.. 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 26 Mar 2007.