Acute Myelogenous LeukemiaPhase 1/2NCT00297921
A Phase 2 Study of Tandutinib in Patients With Newly Diagnosed Acute Myelogenous Leukemia Who Are Considered Ineligible For or Who Decline Treatment With Standard Induction Therapy
A Phase 1/2 study testing tandutinib in people with Acute Myelogenous Leukemia, run by Millennium Pharmaceuticals, Inc..
Trial summary
Prospective, nonrandomized, noncomparative, open-label, multicenter, 2-stage clinical study designed to determine the overall response (combined complete remission, complete remission with incomplete blood count recovery, partial remission, or blast response) rate following tandutinib therapy in 2 groups of patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia
- What is being tested?
- tandutinib
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age
- Unequivocal histologic or cytologic diagnosis of AML (based on the WorldHealth Organization [WHO] and/or FAB classifications), excluding acute promyelocytic leukemia (FAB M3).
- AML patients with a history of antecedent MDS or MPD are eligible for treatment in this study.
- In the opinion of the investigator is ineligible for or has declined treatment with standard induction therapy
- ECOG performance status of equal to or less then 3
- Ability to voluntarily provide written informed consent
- Determination of the presence or absence of a FLT3-ITD mutation before enrollment once it is ascertained that determination of FLT3-ITD mutation status is required to avoid exceeding enrollment in either patient group
Who cannot join
- Presence of an active malignancy other than AML at the time of study entry
- Documented or suspected central nervous system leukemia involvement
- Known gastrointestinal disease that could interfere with the absorption of oral tandutinib
- Severe central nervous system, pulmonary, renal, or hepatic disease not related to AML
- Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or Class IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities
- QTc >500 milliseconds (ms)
Show all 32Show fewer
- Family history of or congenital QTc prolongation
- Pretreatment laboratory test values as follows:
- Total bilirubin >2.5 x the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) >2.5 x the ULN
- Serum creatinine >4.0 mg/dL
- Known or suspected infection with human immunodeficiency virus
- Known active infection with hepatitis B or hepatitis C
- Known or suspected primary muscular or neuromuscular disease (eg, muscular dystrophy or myasthenia gravis)
- Receipt of prior antineoplastic therapy for leukemia, except that prior therapy with the following is allowed:
- Leukapheresis
- Treatment for hyperleukocytosis with hydroxyurea
- Receipt of prior antineoplastic therapy for MDS, except that prior therapy with the following is allowed:
- Growth factor/cytokine support
- Lenalidomide (Revlimid™)
- Thalidomide (Thalomid®)
- Azacitidine (Vidaza®)
- Decitabine (Dacogen)
- Receipt of prior antineoplastic therapy for MPD, except that prior therapy with the following is allowed:
- Interferon alpha
- Anagrelide (Agrylin®)
- Hydroxyurea
- Antineoplastic, experimental, or radiation therapy within 3 weeks before Day 1, except that hydroxyurea for the treatment of hyperleukocytosis is permitted
- Major surgery within 2 weeks before Day 1
- Men or women of childbearing potential unwilling to use adequate contraception from screening to 30 days after the last dose of tandutinib
- A woman who is pregnant or breast feeding. Confirmation that the patient is not pregnant must be established by a negative serum or urine B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during the screening period. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
About this study
Prospective, nonrandomized, noncomparative, open-label, multicenter, 2-stage clinical study designed to determine the overall response (combined complete remission, complete remission with incomplete blood count recovery, partial remission, or blast response) rate following tandutinib therapy in 2 groups of patients with newly diagnosed Acute Myelogenous Luekemia.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- tandutinib
- 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.
tandutinibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous 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 1/2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297921
- Sponsor's protocol ID
- C03002
- Status last verified
- Nov 2013
- First submitted
- 27 Feb 2006
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Tandutinib in Patients With Newly Diagnosed Acute Myelogenous Leukemia Who Are Considered Ineligible For or Who Decline Treatment With Standard Induction Therapy
- ClinicalTrials.gov ID
- NCT00297921
- Acronym / sponsor ID
- C03002
- Conditions
- Acute Myelogenous Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 1 Mar 2006 (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.
Prospective, nonrandomized, noncomparative, open-label, multicenter, 2-stage clinical study designed to determine the overall response (combined complete remission, complete remission with incomplete blood count recovery, partial remission, or blast response) rate following tandutinib therapy in 2 groups of patients with newly diagnosed Acute Myelogenous Luekemia.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, at least 18 years of age
- Unequivocal histologic or cytologic diagnosis of AML (based on the WorldHealth Organization [WHO] and/or FAB classifications), excluding acute promyelocytic leukemia (FAB M3).
- AML patients with a history of antecedent MDS or MPD are eligible for treatment in this study.
- In the opinion of the investigator is ineligible for or has declined treatment with standard induction therapy
- ECOG performance status of equal to or less then 3
Key exclusion criteria (32 listed)
- Presence of an active malignancy other than AML at the time of study entry
- Documented or suspected central nervous system leukemia involvement
- Known gastrointestinal disease that could interfere with the absorption of oral tandutinib
- Severe central nervous system, pulmonary, renal, or hepatic disease not related to AML
- Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or Class IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities
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 |
|---|---|---|
| tandutinib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tandutinib in people with Acute Myelogenous Leukemia, run by Millennium Pharmaceuticals, Inc..
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 7 inclusion and 32 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: withdrawn, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 6 Nov 2013.