Metastatic Solid TumorsPhase 1NCT00827203
A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors
A Phase 1 study testing Elesclomol Sodium in people with Metastatic Solid Tumors, run by Synta Pharmaceuticals Corp. at 3 sites in United States.
Trial summary
The aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose). This study will also characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumors
- What is being tested?
- Elesclomol Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2009to Jan 2011
- 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
- Males and females at least 18 years of age
- Histologically- or cytologically- confirmed solid tumor (except melanoma) that is metastatic or unresectable
- Advanced or metastatic cancer for which no standard therapy exists or that has progressed despite standard therapy
- Acceptable organ and marrow function during the Screening Period as defined by the protocol.
- Reliable venous access suitable for weekly study drug infusions
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Who cannot join
- Pregnant or breast-feeding women
- Have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Primary brain tumors or active brain metastases
- Treatment with chronic immunosuppressants
- Significant cardiovascular disease, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration
Trial locations and contacts
3 sites in 1 country.
United States3 sites
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 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors
The aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose). This study will also characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and unresectable.
- Conditions
- Metastatic Solid Tumors
- Being tested
- Elesclomol Sodium
- Keywords
- cancer, metastatic, Elesclomol Sodium, tumor, Advanced solid tumors that are metastatic and unresectable
- Medical subject headings
- 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
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Not described Receives: Drug: Elesclomol Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors
Measured: Jan 2011
To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion
Measured: Jan 2011
Secondary outcomes (3)
To inform dose selection for future study using a once-a-week schedule
Measured: Jan 2011
To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable
Measured: Jan 2011
To assess the effect of elesclomol sodium on the development of peripheral neuropathy by rating sensory symptoms, strength, tendon reflexes, and vibratory sense
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 posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorsStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827203
- Sponsor's protocol ID
- 4783-11
- Status last verified
- Mar 2009
- First submitted
- 20 Jan 2009
- Last updated
- 9 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00827203
- Acronym / sponsor ID
- 4783-11
- Conditions
- Metastatic Solid Tumors
- Keywords
- cancer, metastatic, Elesclomol Sodium, tumor, Advanced solid tumors that are metastatic and unresectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 22 Jan 2009 (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 aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose). This study will also characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and unresectable.
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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females at least 18 years of age
- Histologically- or cytologically- confirmed solid tumor (except melanoma) that is metastatic or unresectable
- Advanced or metastatic cancer for which no standard therapy exists or that has progressed despite standard therapy
- Acceptable organ and marrow function during the Screening Period as defined by the protocol.
- Reliable venous access suitable for weekly study drug infusions
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding women
- Have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Primary brain tumors or active brain metastases
- Treatment with chronic immunosuppressants
- Significant cardiovascular disease, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration
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 |
Primary outcome
To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors
Time frame: Jan 2011
To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion
Time frame: Jan 2011
3 secondary outcomes
To inform dose selection for future study using a once-a-week schedule
Time frame: Jan 2011
To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable
Time frame: Jan 2011
To assess the effect of elesclomol sodium on the development of peripheral neuropathy by rating sensory symptoms, strength, tendon reflexes, and vibratory sense
Time frame: Jan 2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 in people with Metastatic Solid Tumors, run by Synta Pharmaceuticals Corp. at 3 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 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: paused, as of the sponsor's last update on 9 Mar 2009. 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. 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?
Results are not available in the source record.
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 elesclomol sodium administered once weekly to subjects with solid tumors (time frame: Jan 2011). The study lists 2 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 9 Mar 2009.