Acute Myeloid LeukemiaPhase 1NCT01280786
Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study testing Elesclomol Sodium in people with Acute Myeloid Leukemia, run by Synta Pharmaceuticals Corp. at 1 site in Canada.
Trial summary
This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Elesclomol Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Aug 2014
- 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
- Adults with cytologically confirmed Acute Myeloid Leukemia (AML) that has relapsed after the completion of induction and/or consolidation therapy or has failed to respond to standard induction therapy
- ECOG performance status of 0-2
- Acceptable organ and marrow function during the screening period as defined by the protocol
- Reliable venous access suitable for study drug infusions
Who cannot join
- Significant cardiovascular disease
- Candidates for hematopoietic stem cell transplant
- Women who are pregnant or breast-feeding
- Prior treatment with chronic immunosuppressants
- Other clinically significant uncontrolled conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia
This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.
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 administered to patients with advanced myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Elesclomol Sodium
- Keywords
- AML, leukemia, relapsed or refractory AML
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elesclomol SodiumDrug
Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Elesclomol Sodium | Experimental | Not described Receives: Drug: Elesclomol Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
- Characterize the safety and tolerability of elesclomol sodium administered to subjects with relapsed or refractory acute myeloid leukemia (AML)
Measured: 1 year
Measurement of study drug concentrations to characterize pharmacokinetics.
- Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML).
Measured: 1 year
Secondary outcomes (1)
Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow
- Determine the optimal Phase II dose and preliminary activity for elesclomol sodium in subjects with acute myeloid leukemia (AML).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280786
- Sponsor's protocol ID
- Synta 4783-14
- Status last verified
- Jan 2014
- First submitted
- 14 Jan 2011
- 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 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01280786
- Acronym / sponsor ID
- Synta 4783-14
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, leukemia, relapsed or refractory AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 21 Jan 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.
This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.
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 administered to patients with advanced myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elesclomol Sodium | 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 (4 listed)
- Adults with cytologically confirmed Acute Myeloid Leukemia (AML) that has relapsed after the completion of induction and/or consolidation therapy or has failed to respond to standard induction therapy
- ECOG performance status of 0-2
- Acceptable organ and marrow function during the screening period as defined by the protocol
- Reliable venous access suitable for study drug infusions
Key exclusion criteria (5 listed)
- Significant cardiovascular disease
- Candidates for hematopoietic stem cell transplant
- Women who are pregnant or breast-feeding
- Prior treatment with chronic immunosuppressants
- 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 SodiumWeekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle. | Drug | Elesclomol Sodium |
Primary outcome
Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
Time frame: 1 year
- Characterize the safety and tolerability of elesclomol sodium administered to subjects with relapsed or refractory acute myeloid leukemia (AML)
Measurement of study drug concentrations to characterize pharmacokinetics.
Time frame: 1 year
- Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML).
1 secondary outcome
Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow
Time frame: 1 year
Results and safety
Results are not available in the source record.
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.
1 site 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 Acute Myeloid Leukemia, run by Synta Pharmaceuticals Corp. at 1 site in Canada.
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 4 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 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 1 site in Canada. 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?
Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability. (time frame: 1 year). 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 3 Feb 2014.