Acute Myelogenous Leukemia (AML)Phase 1NCT01265199
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk Acute Myelogenous Leukemia (AML)
A Phase 1 study testing AT-406 in combination with daunorubicin and cytarabine in people with Acute Myelogenous Leukemia (AML), run by Ascenta Therapeutics at 6 sites in United States.
Trial summary
The main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help determine how AT-406… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Acute Myelogenous Leukemia (AML)
- What is being tested?
- AT-406 in combination with daunorubicin and cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 29 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2011to Jan 2013
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or females patients ages 18 to 74
- Morphological diagnosis of untreated or relapsed non-M3 AML according to WHO diagnostic criteria who exhibit at least one poor-risk feature and are not be known to exhibit any favorable cytogenetic features or variants.
- Patients with relapsed AML and patients with prior autologous or allogeneic hematopoietic stem cell transplantations are eligible if relapse occurred following a remission of ≥ 6 months.
- Patients must have an ECOG score of ≤ 2,
- Adequate cardiac, liver and renal function.
Who cannot join
- Must not have any evidence of CNS leukemia.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan Health System
Ann Arbor, Michigan
Univerity of Chicago
Chicago, Illinois
Memorial Sloan Kettering Cancer Center
New York, New York
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania
Temple University at Jeanes Hospital
Philadelphia, Pennsylvania
Washington University at St. Louis Siteman Cancer Center
St Louis, Missouri
About this study
Official title: Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk, Acute Myelogenous Leukemia (AML)
The main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help determine how AT-406 works. Side effects will also be studied in an effort to make sure that this drug is safe to take.
Read the detailed description
This is an open label, multi-center, dose escalation study to determine the MTD of oral AT-406 combined with daunorubicin and cytarabine in patients with poor-risk AML. Treatment with AT-406 will be administered to up to 60 patients at approximately 7 investigational sites in the US. Patients will be enrolled in open label sequential cohorts of up to 12 patients to determine the MTD of AT-406 in combination with daunorubicin and cytarabine. Dose finding will occur during the induction cycle of the regimen. AT-406 will not be administered in consolidation cycles. Patients who require re-induction during initial treatment will be removed from the study and replaced (if needed) in order to assess at least 3 evaluable patients at each dose level.
Clinical and laboratory parameters will be assessed to evaluate the toxicity of AT-406. In addition, pharmacokinetic (PK) and pharmacodynamic (PDy) blood samples will be analyzed for plasma concentrations and PDy effect of AT-406, respectively.
- Conditions
- Acute Myelogenous Leukemia (AML)
- Being tested
- AT-406 in combination with daunorubicin and cytarabine
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-406 in combination with daunorubicin and cytarabineDrug
Oral AT-406 (capsule) given once daily on days 1-5 of induction therapy with daunorubicin 90 mg/m2 I.v. on days 1-3 and cytarabine 100 mg/m2 i.v. by continuous infusion on days 107 of induction therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of oral AT-406 in combination with daunorubicin and cytarabine.
Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of AT-101.
Measured: 15 months
Secondary outcomes (1)
Determine the pharmacokinetic profile of AT-406 and daunorubicin and cytarabine
To determine how the drug is absorbed, distributed, metabolized, and eliminated by the body.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Study was terminated before a MTD was determined for administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous Leukemia (AML)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascenta Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society
- Responsible party
- Sponsor
- Investigators
- J. Mel Sorensen, MD, Study director, Ascenta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265199
- Sponsor's protocol ID
- AT-406-CS-002
- Status last verified
- Jan 2013
- First submitted
- 20 Dec 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk, Acute Myelogenous Leukemia (AML)
- ClinicalTrials.gov ID
- NCT01265199
- Acronym / sponsor ID
- AT-406-CS-002
- Conditions
- Acute Myelogenous Leukemia (AML)
- Keywords
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated before a MTD was determined for administrative reasons
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ascenta TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Dec 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 main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help determine how AT-406 works. Side effects will also be studied in an effort to make sure that this drug is safe to take.
Detailed description
This is an open label, multi-center, dose escalation study to determine the MTD of oral AT-406 combined with daunorubicin and cytarabine in patients with poor-risk AML. Treatment with AT-406 will be administered to up to 60 patients at approximately 7 investigational sites in the US. Patients will be enrolled in open label sequential cohorts of up to 12 patients to determine the MTD of AT-406 in combination with daunorubicin and cytarabine. Dose finding will occur during the induction cycle of the regimen. AT-406 will not be administered in consolidation cycles. Patients who require re-induction during initial treatment will be removed from the study and replaced (if needed) in order to assess at least 3 evaluable patients at each dose level.
Clinical and laboratory parameters will be assessed to evaluate the toxicity of AT-406. In addition, pharmacokinetic (PK) and pharmacodynamic (PDy) blood samples will be analyzed for plasma concentrations and PDy effect of AT-406, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or females patients ages 18 to 74
- Morphological diagnosis of untreated or relapsed non-M3 AML according to WHO diagnostic criteria who exhibit at least one poor-risk feature and are not be known to exhibit any favorable cytogenetic features or variants.
- Patients with relapsed AML and patients with prior autologous or allogeneic hematopoietic stem cell transplantations are eligible if relapse occurred following a remission of ≥ 6 months.
- Patients must have an ECOG score of ≤ 2,
- Adequate cardiac, liver and renal function.
Key exclusion criteria (1 listed)
- Must not have any evidence of CNS leukemia.
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 |
|---|---|---|
| AT-406 in combination with daunorubicin and cytarabineOral AT-406 (capsule) given once daily on days 1-5 of induction therapy with daunorubicin 90 mg/m2 I.v. on days 1-3 and cytarabine 100 mg/m2 i.v. by continuous infusion on days 107 of induction therapy. | Drug | – |
Primary outcome
Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of oral AT-406 in combination with daunorubicin and cytarabine.
Time frame: 15 months
Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of AT-101.
1 secondary outcome
Determine the pharmacokinetic profile of AT-406 and daunorubicin and cytarabine
Time frame: 15 months
Results and safety
The study was stopped early (reason given: Study was terminated before a MTD was determined for administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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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.
J. Mel Sorensen, MD study director
Ascenta Therapeutics, Inc.
6 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 AT-406 in combination with daunorubicin and cytarabine in people with Acute Myelogenous Leukemia (AML), run by Ascenta Therapeutics at 6 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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was stopped early (reason given: Study was terminated before a MTD was determined for administrative reasons). 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?
Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of oral AT-406 in combination with daunorubicin and cytarabine. (time frame: 15 months). 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 23 Jan 2013; AzTrials last refreshed its copy on 26 Oct 2026.