NeoplasmsPhase 1NCT00256191
Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies
A Phase 1 study testing TPI 287 Injection in people with Neoplasms and Hodgkin's Disease, run by Cortice Biosciences, Inc. at 1 site in United States.
Trial summary
Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neoplasms, Hodgkin's Disease, Non-Hodgkin's Lymphoma
- What is being tested?
- TPI 287 Injection
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Feb 2007
- 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
- Patients must be/have:
- Histological evidence of malignancy
- Advanced solid tumors that have recurred or progressed following standard therapy
- Failed one prior therapy or have no standard therapy available
- Ambulatory with ECOG of 0-1 and estimated life expectancy of > 3 months
- If female, negative pregnancy test
- If of childbearing years, agree to use birth control
- If patient with prior radiation therapy for brain metastases, on steroids, must have been stable for 1 month
Who cannot join
- Patients will be excluded if they are or have had:
- Prior radiation within 4 weeks
- Active medical condition or organ disease which may compromise safety or interfere with the study
- Clinically significant cardiac co-morbidities or pulmonary impairment
- Concomitant therapy needs
- Treated with any investigational drugs within 30 days
Show all 18Show fewer
- Tumors involve major artery or vein
- Prior or concurrent central nervous system (CNS) disease
- Less than 4 weeks since major surgery
- Known to be positive for HIV, hepatitis B or C
- Concurrent use of aspirin
- Use of thrombolytic agents
- Uncontrolled hypertension
- Grade II-IV peripheral vascular disease
- Pregnant or lactating
- Prior allergic history to compounds of similar chemical composition
- Inpatients
- Grade II-IV peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Cancer Center
Denver, Colorado, 80218
About this study
Official title: A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies
Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose escalation, sequential group, Phase 1 study evaluating the intravenous administration of TPI 287 on an every 21 day cycle.
Read the detailed description
The primary objective of this study is to determine the maximum tolerated dose of TPI 287 administered every 21 days for Phase II clinical trials.
- Conditions
- Neoplasms, Hodgkin's Disease, Non-Hodgkin's Lymphoma
- Being tested
- TPI 287 Injection
- Keywords
- taxanes, multidrug resistance, mutant tubulin binding, Hodgkin's or Non-Hodgkin's Lymphoma
- Medical subject headings
- Neoplasms, Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI 287 InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose of TPI 287 administered every 21 days
Secondary outcomes (3)
To determine the safety of TPI 287
To determine the antitumor activity of TPI 287
To determine the pharmacokinetic profile of TPI 287
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startNov 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Cortice Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sandra Silberman, MD, Study director, Tapestry Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256191
- Sponsor's protocol ID
- TPI 287-02
- Status last verified
- Nov 2005
- First submitted
- 16 Nov 2005
- Last updated
- 15 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00256191
- Acronym / sponsor ID
- TPI 287-02
- Conditions
- Neoplasms, Hodgkin's Disease, Non-Hodgkin's Lymphoma
- Keywords
- taxanes, multidrug resistance, mutant tubulin binding, Hodgkin's or Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Cortice Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 21 Nov 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.
Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose escalation, sequential group, Phase 1 study evaluating the intravenous administration of TPI 287 on an every 21 day cycle.
Detailed description
The primary objective of this study is to determine the maximum tolerated dose of TPI 287 administered every 21 days for Phase II clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological evidence of malignancy
- Advanced solid tumors that have recurred or progressed following standard therapy
- Failed one prior therapy or have no standard therapy available
- Ambulatory with ECOG of 0-1 and estimated life expectancy of > 3 months
- If female, negative pregnancy test
Key exclusion criteria (18 listed)
- Prior radiation within 4 weeks
- Active medical condition or organ disease which may compromise safety or interfere with the study
- Clinically significant cardiac co-morbidities or pulmonary impairment
- Concomitant therapy needs
- Treated with any investigational drugs within 30 days
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 |
|---|---|---|
| TPI 287 Injection | Drug | – |
Primary outcome
To determine the maximum tolerated dose of TPI 287 administered every 21 days
3 secondary outcomes
To determine the safety of TPI 287
To determine the antitumor activity of TPI 287
To determine the pharmacokinetic profile of TPI 287
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 15 Oct 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.
Sandra Silberman, MD study director
Tapestry Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TPI 287 Injection in people with Neoplasms and Hodgkin's Disease, run by Cortice Biosciences, Inc. at 1 site 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 8 inclusion and 18 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 15 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine the maximum tolerated dose of TPI 287 administered every 21 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 15 Oct 2007.