Prostate CancerPhase 2NCT01296243
Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer
A Phase 2 study testing Tesetaxel in people with Prostate Cancer, run by Genta Incorporated at 4 sites in United States.
Trial summary
Given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Tesetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2011to Feb 2015
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Histologically confirmed prostate cancer, currently with progressive disease
- Evidence of metastatic disease
- Castrate level of testosterone (< 50 ng/dL)
- Eastern Cooperative Oncology Group performance status 0 or 1
- Chemotherapy-naïve
- Adequate bone marrow, hepatic, and renal function
- Ability to swallow an oral solid-dosage form of medication
Who cannot join
- History or presence of brain metastasis or leptomeningeal disease
- Operable cancer
- Uncontrolled diarrhea
- Uncontrolled nausea or vomiting
- Known malabsorptive disorder
- Currently active second malignancy other than non-melanoma skin cancers
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- Human immunodeficiency virus (HIV) infection based on history of positive serology
- Significant medical disease other than cancer
- Presence of neuropathy > Grade 2 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; v4.0)
- Need for other anticancer treatment
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
- Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
- Less than 4 weeks since use of another investigational agent
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
University of Michigan Health System
Ann Arbor, Michigan, 48109-5946
Maha Hussain, MD, FACP, 734-936-8906
Maha Hussain, MD, FACP
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
Justine Bruce, MD, 608-262-4961
Justine Y Bruce, MD
- Recruiting
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Tina Mayer, MD, 732-235-8157
Tina Mayer, MD
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Michael J Morris, MD, 646-422-4469, morrism@MSKCC.ORG
Michael J Morris, MD
About this study
Official title: A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer
Given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.
- Conditions
- Prostate Cancer
- Being tested
- Tesetaxel
- Keywords
- Castration-resistant prostate cancer, Tesetaxel, Taxanes, Chemotherapy-naive, Chemotherapy-exposed, Progressive, metastatic castration-resistant prostate cancer
- Medical subject headings
- Prostatic 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 will be administered orally once every 21 days until progression, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria. The duration of protocol therapy will not exceed 12 months. Treatment will be initiated at a dose of 27 mg/m2; dose escalation to a maximum of 35 mg/m2 is allowed in Cycle 2 depending on tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Tesetaxel once every 3 weeks | Experimental | Not described Receives: Drug: Tesetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 6 months from the start of treatment
Secondary outcomes (8)
Response rate (RECIST 1.1) among patients with measurable disease
Measured: 6 months from the start of treatment
Duration of response among patients with measurable disease
Measured: 12 months from the start of treatment
Durable response among patients with measurable disease
Measured: 12 months from the start of treatment
Overall survival
Measured: 3 years following enrollment of the last subject
Disease-control rate
Measured: 6 months from the start of treatment
PSA response rate
Measured: Week 12
Progression-free survival
Measured: 12 months from the start of treatment
No. (percentage) of subjects with adverse events
Measured: Through 30 days after the last dose of tesetaxel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2012 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Morris, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296243
- Sponsor's protocol ID
- TOP205
- Other IDs
- PCCTC LOI # c10-071
- Status last verified
- Jul 2012
- First submitted
- 10 Feb 2011
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01296243
- Acronym / sponsor ID
- TOP205
- Conditions
- Prostate Cancer
- Keywords
- Castration-resistant prostate cancer, Tesetaxel, Taxanes, Chemotherapy-naive, Chemotherapy-exposed, Progressive, metastatic castration-resistant prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 15 Feb 2011 (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.
Given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tesetaxel once every 3 weeks | Experimental | Drug: Tesetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age
- Histologically confirmed prostate cancer, currently with progressive disease
- Evidence of metastatic disease
- Castrate level of testosterone (< 50 ng/dL)
- Eastern Cooperative Oncology Group performance status 0 or 1
Key exclusion criteria (13 listed)
- History or presence of brain metastasis or leptomeningeal disease
- Operable cancer
- Uncontrolled diarrhea
- Uncontrolled nausea or vomiting
- Known malabsorptive disorder
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 will be administered orally once every 21 days until progression, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria. The duration of protocol therapy will not exceed 12 months. Treatment will be initiated at a dose of 27 mg/m2; dose escalation to a maximum of 35 mg/m2 is allowed in Cycle 2 depending on tolerability. | Drug | Tesetaxel once every 3 weeks |
Primary outcome
Progression-free survival
Time frame: 6 months from the start of treatment
8 secondary outcomes
Response rate (RECIST 1.1) among patients with measurable disease
Time frame: 6 months from the start of treatment
Duration of response among patients with measurable disease
Time frame: 12 months from the start of treatment
Durable response among patients with measurable disease
Time frame: 12 months from the start of treatment
Overall survival
Time frame: 3 years following enrollment of the last subject
Disease-control rate
Time frame: 6 months from the start of treatment
PSA response rate
Time frame: Week 12
Progression-free survival
Time frame: 12 months from the start of treatment
No. (percentage) of subjects with adverse events
Time frame: Through 30 days after the last dose of tesetaxel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
Michael J Morris, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: 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 Prostate Cancer, run by Genta Incorporated 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 8 inclusion and 13 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 24 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 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 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?
Progression-free survival (time frame: 6 months from the start of treatment). 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 24 Jul 2012.