AMLPhase 1NCT01074086
Phase I Study in RAD 001 Patients With Relapse AML
A Phase 1 study testing RAD 001 in people with AML, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AML
- What is being tested?
- RAD 001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Dec 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients from 18 to 65 years old
- AML in relapse more than 1 year after CR
- inform consent signed
Who cannot join
- age more than 65
- cardiac insufficiency
- renal insufficiency
- hepatic disease
- other type of AML
- blastic MCL
Show all 9Show fewer
- HIV positive serology
- other malignancy
- pulmonary infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Study of GOELAMS Phase I Evaluation of RAD001 in Association With Aracytine and Daunorubicine in AML Treatment in Patients Less Than 65 Years in Relapse More Than One Year After First Complete Remission
A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse
Read the detailed description
The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.
- Conditions
- AML
- Being tested
- RAD 001
- Keywords
- RAD 001 in relapsed AML
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD 001Drug
Also called everolimus
RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg
| Study group | Role | What they receive |
|---|---|---|
| RAD 001 | Experimental | RAD 001 in day 1 and day 7 from 10 mg to 50 mg Receives: Drug: RAD 001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal dose tolerated
5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step
Measured: 40 days
Secondary outcomes (2)
Biological study
biological study of PI3K/AKT an mTORC1 activation in blast cells
Measured: Day 1 and day 7
Biological study
concentration mesures of RAD 001 in total blood
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startFeb 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AMLStudies 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
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Sophie PARK, MD MS, Principal investigator, French Innovative Leukemia OrganisationDidier BOUSCArY, MD MS, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074086
- Sponsor's protocol ID
- RAD 001
- Status last verified
- Dec 2012
- First submitted
- 22 Feb 2010
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park S, Chapuis N, Saint Marcoux F, Recher C, Prebet T, Chevallier P, Cahn JY, Leguay T, Bories P, Witz F, Lamy T, Mayeux P, Lacombe C, Demur C, Tamburini J, Merlat A, Delepine R, Vey N, Dreyfus F, Bene MC, Ifrah N, Bouscary D; GOELAMS (Groupe Ouest Est d'Etude des Leucemies aigues et Autres Maladies du Sang). A phase Ib GOELAMS study of the mTOR inhibitor RAD001 in association with chemotherapy for AML patients in first relapse. Leukemia. 2013 Jul;27(7):1479-86. doi: 10.1038/leu.2013.17. Epub 2013 Jan 16.
PubMed 23321953
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study of GOELAMS Phase I Evaluation of RAD001 in Association With Aracytine and Daunorubicine in AML Treatment in Patients Less Than 65 Years in Relapse More Than One Year After First Complete Remission
- ClinicalTrials.gov ID
- NCT01074086
- Acronym / sponsor ID
- RAD 001
- Conditions
- AML
- Keywords
- RAD 001 in relapsed AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Feb 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Feb 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.
A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse
Detailed description
The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.
Study design
- Primary purpose
- Treatment
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD 001 | Experimental | Drug: RAD 001RAD 001 in day 1 and day 7 from 10 mg to 50 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients from 18 to 65 years old
- AML in relapse more than 1 year after CR
- inform consent signed
Key exclusion criteria (9 listed)
- age more than 65
- cardiac insufficiency
- renal insufficiency
- hepatic disease
- other type of AML
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 |
|---|---|---|
| RAD 001Also: everolimusRAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg | Drug | RAD 001 |
Primary outcome
maximal dose tolerated
Time frame: 40 days
5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step
2 secondary outcomes
Biological study
Time frame: Day 1 and day 7
Biological study
Time frame: Day 1 and Day 7
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 24 Dec 2012.
- Derived from this study: PubMed 23321953Park S, Chapuis N, Saint Marcoux F, Recher C, Prebet T, Chevallier P, Cahn JY, Leguay T, Bories P, Witz F, Lamy T, Mayeux P, Lacombe C, Demur C, Tamburini J, Merlat A, Delepine R, Vey N, Dreyfus F, Bene MC, Ifrah N, Bouscary D; GOELAMS (Groupe Ouest Est d'Etude des Leucemies aigues et Autres Maladies du Sang). A phase Ib GOELAMS study of the mTOR inhibitor RAD001 in association with chemotherapy for AML patients in first relapse. Leukemia. 2013 Jul;27(7):1479-86. doi: 10.1038/leu.2013.17. Epub 2013 Jan 16.
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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.
Sophie PARK, MD MS principal investigator
French Innovative Leukemia Organisation
Didier BOUSCArY, MD MS principal investigator
French Innovative Leukemia Organisation
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 RAD 001 in people with AML, run by French Innovative Leukemia Organisation at 1 site in France.
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 9 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 24 Dec 2012. 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 France. 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?
maximal dose tolerated (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074086, which also lists 1 linked publication.
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 24 Dec 2012.