NeoplasmsPhase 1NCT00113724
Study of TPI 287 in Patients With Advanced Malignancies
A Phase 1 study testing TPI 287 Injection in people with Neoplasms and Non-Hodgkin Lymphoma, run by Cortice Biosciences, Inc. at 4 sites 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 years and older
- Conditions the study is for
- Neoplasms, Non-Hodgkin Lymphoma, Hodgkin Disease
- What is being tested?
- TPI 287 Injection
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2005to Jan 2008
- 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
- Histological or cytological evidence of malignancy
- Patients must have either:
- advanced solid tumors that have recurred or progressed following standard therapy, or
- Hodgkin's or non-Hodgkin's lymphoma that has recurred or progressed following standard therapy, have not had a previous bone marrow transplant, and are not eligible for a bone marrow transplant.
- Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
- Ambulatory with ECOG 0 or 1, and a life expectancy of >3 months.
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- Judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
- Have ability to read, understand and provide written informed consent for the initiation of any study related procedures or have a legal representative to perform this function.
- If female, must have a negative pregnancy test within 21 days of start of treatment.
- Agree to the use of an effective method of contraception during the study and for 90 days following the last dose of medication.
- Patients with prior radiation therapy for brain metastasis or primary brain tumors are acceptable.
Who cannot join
- Prior radiation therapy or chemotherapy within 4 weeks (6 weeks for prior nitrosoureas or mitomycin)
- Another active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome evaluation of the study drug. While this exclusion is not limited to the following abnormalities, if any of the following laboratory abnormalities are present, the patient should be excluded:
- WBC < 3000/uL;
- Absolute neutrophil count < 1500/uL;
- Platelets < 100,000/uL;
- Total bilirubin > 1.5 x upper limit of normal;
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- ALT or AST > 3 x upper limit of normal if no liver metastases or >5 upper limit of normal in the presence of liver metastases;
- Serum creatinine > 1.5 x upper limit of normal;
- INR >2.0.
- Patient has clinically significant cardiac co-morbidities or pulmonary impairment
- Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study. Of note, therapy with LHRH for prostate cancer is acceptable.
- Patient has been treated with any investigational drug, investigational biologic, or investigational therapeutic device within 30 days of initiating study treatment.
- Tumor appears to involve a major artery or vein.
- Prior or concurrent significant CNS disease including stroke, except for primary or secondary malignancies.
- Less than 4 weeks since prior major surgery
- Known positive for HIV, Hepatitis B or C
- Concurrent chronic use of aspirin (325 mg/day or more)
- Concurrent or recent (within 1 month) use of thrombolytic agents, or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters) Of note, therapy with low-molecular weight heparin is acceptable as long as the INR<2.0.
- Uncontrolled hypertension
- Grade II-IV peripheral vascular disease within the past year
- Prior allergic reactions to compounds of similar chemical or biologic composition to TPI 287, paclitaxel or taxotere, Cremophor-EL-P, or other study agents
- Significant traumatic injury within the past 4 weeks
- Ongoing or active infection requiring parenteral antibiotics or with a fever >38.1°C within 3 days of the first scheduled day of dosing
- Other concurrent uncontrolled illness which may interfere with the ability of the patient to participate in the trial
- Patients who are inpatients
- Grade II-IV peripheral neuropathy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Arizona Clinical Research Center
Tucson, Arizona, 85715
New York Medical College
Valhalla, New York, 10595
Georgetown University Medical Center/Lombardi Cancer Center
Washington D.C., District of Columbia, 20007-2113
About this study
Official title: A Phase I, Open-Label, 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 I study evaluating the intravenous administration of TPI 287, a novel third generation taxane.
Read the detailed description
The primary objective of this study is to determine the maximum tolerated dose of TPI 287 for phase II clinical trials.
The secondary objectives of the study are:
- To determine the safety of TPI 287
- To determine antitumor activity of TPI 287
- To determine the pharmacokinetic profile of TPI 287
- To determine the pharmacodynamic profile of TPI 287
- Conditions
- Neoplasms, Non-Hodgkin Lymphoma, Hodgkin Disease
- Being tested
- TPI 287 Injection
- Keywords
- taxane, multi-drug resistance, mutant tubulin binding, Advanced malignancies, Hodgkin's or Non-Hodgkin's Lymphoma
- Medical subject headings
- Neoplasms, Lymphoma, Non-Hodgkin, Hodgkin Disease
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
Secondary outcomes (4)
To determine the safety of TPI 287
To determine the antitumor activity of TPI 287
To determine the pharmacokinetic profile of TPI 287
To determine the pharmacodynamic 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 posted10 Jun 2005 (estimated)
- Study startMay 2005
- Primary completionJan 2008
- Study completionJan 2008
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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cortice Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Kurman, MD, Study director, Tapestry Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113724
- Sponsor's protocol ID
- TPI 287-01
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2005
- Last updated
- 4 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00113724
- Acronym / sponsor ID
- TPI 287-01
- Conditions
- Neoplasms, Non-Hodgkin Lymphoma, Hodgkin Disease
- Keywords
- taxane, multi-drug resistance, mutant tubulin binding, Advanced malignancies, Hodgkin's or Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cortice Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Jun 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 I study evaluating the intravenous administration of TPI 287, a novel third generation taxane.
Detailed description
The primary objective of this study is to determine the maximum tolerated dose of TPI 287 for phase II clinical trials.
The secondary objectives of the study are:
- To determine the safety of TPI 287
- To determine antitumor activity of TPI 287
- To determine the pharmacokinetic profile of TPI 287
- To determine the pharmacodynamic profile of TPI 287
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (11 listed)
- Histological or cytological evidence of malignancy
- Patients must have either:
- Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
- Ambulatory with ECOG 0 or 1, and a life expectancy of >3 months.
- Judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
Key exclusion criteria (26 listed)
- Prior radiation therapy or chemotherapy within 4 weeks (6 weeks for prior nitrosoureas or mitomycin)
- Another active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome evaluation of the study drug. While this exclusion is not limited to the following abnormalities, if any of the following laboratory abnormalities are present, the patient should be excluded:
- Patient has clinically significant cardiac co-morbidities or pulmonary impairment
- Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study. Of note, therapy with LHRH for prostate cancer is acceptable.
- Patient has been treated with any investigational drug, investigational biologic, or investigational therapeutic device within 30 days of initiating study 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 |
|---|---|---|
| TPI 287 Injection | Drug | – |
Primary outcome
To determine the maximum tolerated dose of TPI 287
4 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
To determine the pharmacodynamic 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 4 Jun 2009.
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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.
Michael Kurman, MD study director
Tapestry Pharmaceuticals, Inc.
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 TPI 287 Injection in people with Neoplasms and Non-Hodgkin Lymphoma, run by Cortice Biosciences, Inc. 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 11 inclusion and 26 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 4 Jun 2009. 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.
What does the primary outcome measure?
To determine the maximum tolerated dose of TPI 287. 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 4 Jun 2009.