Carcinoma, Transitional CellPhase 2NCT01215877
Tesetaxel for Previously Treated Patients With Bladder Cancer
A Phase 2 study testing Tesetaxel in people with Carcinoma, Transitional Cell, run by Genta Incorporated at 3 sites in 2 countries.
Trial summary
The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Transitional Cell
- What is being tested?
- Tesetaxel
- Type of treatment
- Pill or oral medicine
- How many people
- 33 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2010to Dec 2012
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis
- Measurable disease (revised RECIST; Version 1.1)
- Karnofsky performance status ≥ 60%
- Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent
- Adequate bone marrow, hepatic, and renal function, as specified in the protocol
- At least 4 weeks and recovery from effects of prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent
- Ability to swallow an oral solid-dosage form of medication
Who cannot join
- Known metastasis or symptoms of metastasis to the central nervous system
- Significant medical disease other than cancer
- Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
- Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Dean F Bajorin, MD, 646-422-4333
Dean F Bajorin, MD
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Deborah Kilpatrick, 215-955-0017, Deborah.Kilpatrick@jefferson.edu
Jean Hoffman-Censits, MD
Italy1 site, 1 recruiting
- Recruiting
San Camillo Forlanini Hospital
Rome, 00152
Cora N Sternberg, MD, FACP, cstern@mclink.it
Cora N Sternberg, MD, FACP
About this study
Official title: A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium
The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients.
Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.
- Conditions
- Carcinoma, Transitional Cell
- Being tested
- Tesetaxel
- Keywords
- Bladder cancer, Previously treated patients, Tesetaxel, Oral taxane
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesetaxelDrug
Also called DJ-927
Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months
In Cycle 1, a dose of 27 mg/m2 will be administered. In subsequent cycles,
- the dose will be increased to 35 mg/m2 in Cycle 2 for subjects who did not have an ANC < 1,500/mm3, a platelet count < 100,000/mm3, or a Grade 3 (or higher grade) nonhematologic adverse event considered by the Investigator to be related to protocol therapy (excluding alopecia, nausea, and vomiting) in Cycle 1. The dose is not to exceed the dose of 35 mg/m2 in any cycle subsequent to Cycle 2.
- for all other subjects, the dose administered in Cycle 1 (27 mg/m2) will be administered in all subsequent cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (revised RECIST)
Proportion of patients with a confirmed complete or partial response
Measured: 12 months from date of first dose of study medication for last patient enrolled
Secondary outcomes (6)
≥ 3-month response rate
Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration
Measured: 12 months from date of first dose of study medication for last patient enrolled
Disease control rate
Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration
Measured: 12 months from date of first dose of study medication for last patient enrolled
Durable response rate
Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration
Measured: 12 months from date of first dose of study medication for last patient enrolled
Duration of response
Date when response criteria are first met to the date when progression is first documented
Measured: 12 months from date of first dose of study medication for last patient enrolled
Time to progression
Date of first dose of study medication to the date when progression is first documented
Measured: 12 months from date of first dose of study medication for last patient enrolled
Safety
Adverse events and clinical laboratory tests
Measured: Up to 30 days after the last dose of study medication for a specific patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Transitional CellStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dean F Bajorin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215877
- Sponsor's protocol ID
- TOBL204
- Status last verified
- Nov 2011
- First submitted
- 5 Oct 2010
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium
- ClinicalTrials.gov ID
- NCT01215877
- Acronym / sponsor ID
- TOBL204
- Conditions
- Carcinoma, Transitional Cell
- Keywords
- Bladder cancer, Previously treated patients, Tesetaxel, Oral taxane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Oct 2010 (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 intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients.
Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (8 listed)
- At least 18 years of age
- Histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis
- Measurable disease (revised RECIST; Version 1.1)
- Karnofsky performance status ≥ 60%
- Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent
Key exclusion criteria (5 listed)
- Known metastasis or symptoms of metastasis to the central nervous system
- Significant medical disease other than cancer
- Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
- Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
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 |
|---|---|---|
| TesetaxelAlso: DJ-927Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months In Cycle 1, a dose of 27 mg/m2 will be administered. In subsequent cycles, * the dose will be increased to 35 mg/m2 in Cycle 2 for subjects who did not have an ANC < 1,500/mm3, a platelet count < 100,000/mm3, or a Grade 3 (or higher grade) nonhematologic adverse event considered by the Investigator to be related to protocol therapy (excluding alopecia, nausea, and vomiting) in Cycle 1. The dose is not to exceed the dose of 35 mg/m2 in any cycle subsequent to Cycle 2. * for all other subjects, the dose administered in Cycle 1 (27 mg/m2) will be administered in all subsequent cycles. | Drug | – |
Primary outcome
Response rate (revised RECIST)
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Proportion of patients with a confirmed complete or partial response
6 secondary outcomes
≥ 3-month response rate
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Disease control rate
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Durable response rate
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Duration of response
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Time to progression
Time frame: 12 months from date of first dose of study medication for last patient enrolled
Safety
Time frame: Up to 30 days after the last dose of study medication for a specific patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
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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.
Thomas Jefferson University Hospital
Philadelphia, United States
Dean F Bajorin, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesetaxel in people with Carcinoma, Transitional Cell, run by Genta Incorporated at 3 sites in 2 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 11 Jul 2012. 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, Italy. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (revised RECIST) (time frame: 12 months from date of first dose of study medication for last patient enrolled). 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 11 Jul 2012.