Acute Myeloid LeukemiaPhase 2NCT01180426
Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia
A Phase 2 study testing CHR-2797 in people with Acute Myeloid Leukemia, run by Chroma Therapeutics at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- CHR-2797
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2010to Jun 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed, informed consent
- Completion of Visit 11 in the OPAL Study (Month 6 Visit)
- Investigator's opinion that the subject would benefit from continued therapy with tosedostat.
Who cannot join
- Any co-existing medical condition that in the Investigator's opinion will substantially increase the risk associated with the subject's participation in the study
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Administration of any (other) investigational agent within 14 days of entry into TOPAZ.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109-2800
Duke University Medical Center
Durham, North Carolina, 27710
John Theurer Cancer Center
Hackensack, New Jersey, 07601
MD Anderson
Houston, Texas, 77030-4009
UCLA Division of Hematology/Oncology
Los Angeles, California, 90095
New York Presbyterian Hospitacl
New York, New York, 10021
About this study
Official title: The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat
The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.
Read the detailed description
Extension protocol to the OPAL Study (CHR-2797-038).
Study mimics normal clinical practice; few procedures and visits are therefore mandated by the protocol. Timing of bone marrow assessment is also left at the investigator's discretion.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- CHR-2797
- Keywords
- Relapse Refractory Acute Myeloid Leukemia
- 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.
CHR-2797Drug
120mg once daily oral for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tosedostat | Experimental | Not described Receives: Drug: CHR-2797 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of extended treatment with tosedostat
Primary outcome will be assessed using the following procedures/data:
- Physical exams
- Vital signs
- Electrocardiography
- Laboratory parameters (hematology, chemistry, urinalysis)
- Adverse events
- Serious adverse events
Measured: Protocol mandated visits every 12 weeks
Secondary outcomes (1)
Efficacy of extended treatment with tosedostat
The secondary outcome will be assessed using the following parameters:
- Overall survival
- Relapse-free survival
- Event-free survival
- Clinical responses (Complete Remission, Complete Remission with Incomplete Platelet Recovery, Morphological Leukemia-Free State, Partial Remission, Stable Disease, Progressive Disease) including best response and time to response
- Duration of clinical responses.
Measured: Protocol-mandated visits every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chroma Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180426
- Sponsor's protocol ID
- CHR-2797-045
- Status last verified
- Feb 2012
- First submitted
- 5 Aug 2010
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat
- ClinicalTrials.gov ID
- NCT01180426
- Acronym / sponsor ID
- CHR-2797-045
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Relapse Refractory Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chroma TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 12 Aug 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 purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.
Detailed description
Extension protocol to the OPAL Study (CHR-2797-038).
Study mimics normal clinical practice; few procedures and visits are therefore mandated by the protocol. Timing of bone marrow assessment is also left at the investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tosedostat | Experimental | Drug: CHR-2797 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed, informed consent
- Completion of Visit 11 in the OPAL Study (Month 6 Visit)
- Investigator's opinion that the subject would benefit from continued therapy with tosedostat.
Key exclusion criteria (3 listed)
- Any co-existing medical condition that in the Investigator's opinion will substantially increase the risk associated with the subject's participation in the study
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Administration of any (other) investigational agent within 14 days of entry into TOPAZ.
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 |
|---|---|---|
| CHR-2797120mg once daily oral for 48 weeks | Drug | Tosedostat |
Primary outcome
Safety and Tolerability of extended treatment with tosedostat
Time frame: Protocol mandated visits every 12 weeks
Primary outcome will be assessed using the following procedures/data: * Physical exams * Vital signs * Electrocardiography * Laboratory parameters (hematology, chemistry, urinalysis) * Adverse events * Serious adverse events
1 secondary outcome
Efficacy of extended treatment with tosedostat
Time frame: Protocol-mandated visits every 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 CHR-2797 in people with Acute Myeloid Leukemia, run by Chroma 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 3 inclusion and 3 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 15 Feb 2012. 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 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?
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?
Safety and Tolerability of extended treatment with tosedostat (time frame: Protocol mandated visits every 12 weeks). 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 15 Feb 2012.