Chronic Myeloid Leukemia (CML)Phase 1NCT00428909
Effect of Imatinib Mesylate and the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
A Phase 1 study testing Imatinib/Acetaminophen in people with Chronic Myeloid Leukemia (CML), run by Novartis Pharmaceuticals at 1 site in South Korea.
Trial summary
A non-randomized, open-label study to investigate the effects of imatinib mesylate on the pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Myeloid Leukemia (CML)
- What is being tested?
- Imatinib/Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2006to Aug 2008
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent prior to participation to the study.
- Male or female patients ≥ 18 and ≤ 75 years of age
- Patients with CML-CP within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis). FISH analysis will not be accepted.
- Diagnosis of CML in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Bcr-Abl
- Documented chronic phase CML as defined by:
- < 15% blasts in peripheral blood and bone marrow
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- < 30% blasts plus promyelocytes in peripheral blood and bone marrow
- < 20% basophils in the peripheral blood
- ≥ 100 x 109/L (≥ 100,000 /mm3) platelets
- No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
- Adequate end organ function as defined by:
- total bilirubin < 1.5 x ULN
- SGOT and SGPT < 2.5 x UNL
- creatinine < 1.5 x ULN
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug
Who cannot join
- Patients in late chronic phase, accelerated phase, or blastic phase are excluded
- Patients who have received other investigational agents
- Patients who received imatinib for any duration prior to study entry
- Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
- Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
- Patients who are:
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- pregnant
- breast feeding
- of childbearing potential without a negative pregnancy test prior to baseline
- male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial
- Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
- Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes, chronic renal disease)
- Patient previously received radiotherapy to ≥ 25% of the bone marrow
- Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
- Patients with an ECOG Performance Status Score ≥ 3
- Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulant
- Patients with known positivity for human immunodeficiency virus (HIV)
- baseline testing for HIV is not required
- Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
- Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment
- Patients who are chronic users of acetaminophen or medications containing acetaminophen.
- Patients who received acetaminophen or medications containing acetaminophen within 72 hours prior to study entry.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-randomized, Open-label Study to Investigate the Effects of Imatinib Mesylate on the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
A non-randomized, open-label study to investigate the effects of imatinib mesylate on the pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP)
- Conditions
- Chronic Myeloid Leukemia (CML)
- Being tested
- Imatinib/Acetaminophen
- Keywords
- Pharmacokinetic, STI571, imatinib, CML, Chronic Myeloid Leukemia, Philadelphia Chromosome, acetaminophen
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib/AcetaminophenDrug
| Study group | Role | What they receive |
|---|---|---|
| Drug-Drug interaction | Other | Not described Receives: Drug: Imatinib/Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effects of the co-administration of imatinib on the pharmacokinetics of acetaminophen / paracetamol
Measured: Day 1, day 2 -7, Day 8
To investigate the pharmacokinetic characteristics of imatinib at steady state in CML-CP patients following 400 mg dosing co-administered with acetaminophen
Measured: Day 1, Day 2-7, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia (CML)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428909
- Sponsor's protocol ID
- CSTI571A2107
- Status last verified
- Apr 2016
- First submitted
- 29 Jan 2007
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open-label Study to Investigate the Effects of Imatinib Mesylate on the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
- ClinicalTrials.gov ID
- NCT00428909
- Acronym / sponsor ID
- CSTI571A2107
- Conditions
- Chronic Myeloid Leukemia (CML)
- Keywords
- Pharmacokinetic, STI571, imatinib, CML, Chronic Myeloid Leukemia, Philadelphia Chromosome, acetaminophen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Jan 2007 (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 non-randomized, open-label study to investigate the effects of imatinib mesylate on the pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug-Drug interaction | Other | Drug: Imatinib/Acetaminophen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ability to provide written informed consent prior to participation to the study.
- Male or female patients ≥ 18 and ≤ 75 years of age
- Patients with CML-CP within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis). FISH analysis will not be accepted.
- Diagnosis of CML in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Bcr-Abl
- Documented chronic phase CML as defined by:
Key exclusion criteria (23 listed)
- Patients in late chronic phase, accelerated phase, or blastic phase are excluded
- Patients who have received other investigational agents
- Patients who received imatinib for any duration prior to study entry
- Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
- Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
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 |
|---|---|---|
| Imatinib/Acetaminophen | Drug | Drug-Drug interaction |
Primary outcome
To investigate the effects of the co-administration of imatinib on the pharmacokinetics of acetaminophen / paracetamol
Time frame: Day 1, day 2 -7, Day 8
To investigate the pharmacokinetic characteristics of imatinib at steady state in CML-CP patients following 400 mg dosing co-administered with acetaminophen
Time frame: Day 1, Day 2-7, Day 8
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 21 Apr 2016.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
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 Imatinib/Acetaminophen in people with Chronic Myeloid Leukemia (CML), run by Novartis Pharmaceuticals at 1 site in South Korea.
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 15 inclusion and 23 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 21 Apr 2016. 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 South Korea. 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?
To investigate the effects of the co-administration of imatinib on the pharmacokinetics of acetaminophen / paracetamol (time frame: Day 1, day 2 -7, Day 8). 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 21 Apr 2016.