Prostate CancerPhase 1NCT00808418
A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer
A Phase 1 study testing Elesclomol Sodium and Docetaxel in people with Prostate Cancer, run by Synta Pharmaceuticals Corp. at 5 sites in United States.
Trial summary
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel. 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?
- Elesclomol Sodium and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2008to May 2010
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed metastatic prostate cancer
- No more than one prior chemotherapy on which the disease progressed
- ECOG performance status of less than or equal to 2
- Adequate bone marrow, renal and hepatic functions as defined in the protocol
- Neuropathy less than or equal to 2
- Reliable venous access for frequent study drug infusions
Who cannot join
- Significant cardiovascular disease
- Known active brain metastases
- Subjects that have received treatment for other malignancies with in the past 5 years
- Other clinically significant uncontrolled conditions
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, 92708
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792
Mayo Clinic
Rochester, Maryland, 55905
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
Read the detailed description
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
- Conditions
- Prostate Cancer
- Being tested
- Elesclomol Sodium, Docetaxel
- Keywords
- prostate, cancer, metastatic, castration, refractory, elesclomol, sodium, docetaxel, prednisone
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elesclomol SodiumDrug
Chemotherapy agent
DocetaxelDrug
Chemotherapy agent
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Not described Receives: Drug: Elesclomol Sodium; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects
Measured: Jan 2011
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel
Measured: Jan 2011
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population
Measured: Jan 2011
Secondary outcomes (3)
To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer
Measured: Jan 2011
Evaluate OS
Measured: Jan 2011
To characterize the pharmacokinetics of elesclomol metabolites
Measured: Jan 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2010
- Study completionMay 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808418
- Sponsor's protocol ID
- 4783-12
- Status last verified
- Jan 2014
- First submitted
- 12 Dec 2008
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
- ClinicalTrials.gov ID
- NCT00808418
- Acronym / sponsor ID
- 4783-12
- Conditions
- Prostate Cancer
- Keywords
- prostate, cancer, metastatic, castration, refractory, elesclomol, sodium, docetaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Dec 2008 (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.
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
Detailed description
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Drug: Elesclomol Sodium, Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed metastatic prostate cancer
- No more than one prior chemotherapy on which the disease progressed
- ECOG performance status of less than or equal to 2
- Adequate bone marrow, renal and hepatic functions as defined in the protocol
- Neuropathy less than or equal to 2
Key exclusion criteria (4 listed)
- Significant cardiovascular disease
- Known active brain metastases
- Subjects that have received treatment for other malignancies with in the past 5 years
- Other clinically significant uncontrolled conditions
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 |
|---|---|---|
| Elesclomol SodiumChemotherapy agent | Drug | Cohort |
| DocetaxelChemotherapy agent | Drug | Cohort |
Primary outcome
To characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects
Time frame: Jan 2011
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel
Time frame: Jan 2011
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population
Time frame: Jan 2011
3 secondary outcomes
To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer
Time frame: Jan 2011
Evaluate OS
Time frame: Jan 2011
To characterize the pharmacokinetics of elesclomol metabolites
Time frame: Jan 2011
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 3 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 Elesclomol Sodium and Docetaxel in people with Prostate Cancer, run by Synta Pharmaceuticals Corp. at 5 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 6 inclusion and 4 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 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects (time frame: Jan 2011). The study lists 3 primary outcomes in all. 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 3 Feb 2014.