Acute Myelogenous LeukemiaPhase 1NCT00346632

An Ascending Dose Study of KW-2449 in Acute Leukemias, Myelodysplastic Syndromes, and Chronic Myelogenous Leukemia

A Phase 1 study testing KW-2449 in people with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia, run by Kyowa Kirin, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in subjects with AML, ALL, MDS and CML. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
What is being tested?: KW-2449
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 4 sitesUnited States
Study dates: Jun 2006to Apr 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Histologically confirmed diagnosis of:
AML (including APL refractory to all-trans retinoic acid and arsenic) that has relapsed or was not responsive to prior chemotherapy;
Relapsed/refractory ALL;
CML that has failed to respond or has lost a response to imatinib; and
Advanced MDS (INT-2 and High risk by IPSS) with failure or intolerance to approved therapy.
ECOG Performance Status score of 0, 1, or 2;

Show all 11Show fewer

Male or female, at least 18 years of age;
Signed written informed consent;
Serum creatinine ≤ 2.0 mg/dL;
Serum SGOT (AST) and SGPT (ALT) ≤ 5x ULN; serum bilirubin ≤ 2 mg/dL (serum bilirubin may be ≤ 3.0 mg/dL in any subject with Gilbert's Syndrome); and
For females of childbearing potential, a negative serum pregnancy test. Subjects, of childbearing potential, must use an Investigator-approved method of birth control.

Who cannot join

Candidates for approved therapies;
Concomitant treatment with any investigational agent, chemotherapy, radiotherapy, or immunotherapy;
Active CNS leukemia;
Previous or concurrent malignancy except noninvasive non-melanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 2 years prior to study entry;
Uncontrolled systemic infection (viral, bacterial, or fungal);
Uncontrollable disseminated intravascular coagulation;

Show all 20Show fewer

Major surgery within the 28 days preceding the first dose KW-2449;
Radiotherapy, or lack of recovery of any radiotherapy-related acute toxicity, within the 28 days preceding the first dose KW-2449;
Treatment with systemic therapy for the underlying hematologic condition, or lack of recovery of toxicity from such treatment, within 28 days of the first dose of KW-2449, with the following exceptions: hydroxyurea for treatment of hyperleukocytosis (discontinued for at least 48 hours prior to the first dose of KW-2449); imatinib (discontinued for at least 48 hours prior to the first dose of KW-2449); and interferon (discontinued for at least 7 days prior to the first dose of KW-2449);
Treatment with any other investigational agent, or lack of recovery of toxicity from such treatment, within the 28 days preceding the first dose of KW-2449;
Positive serology for HIV;
Clinically significant cardiac dysfunction (New York Heart Association Class 3 or 4) at the time of screening, or a history of myocardial infarction or heart failure within 3 months preceding the first dose of KW-2449;
Any evidence of chronic Graft versus Host Disease;
Active autoimmune disease requiring immunosuppressive therapy;
Female subjects who are pregnant or breast feeding;
Subjects of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards;
Known current drug or alcohol abuse;
Other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may compromise the safety of the subject during the study, affect the subject's ability to complete the study, or interfere with interpretation of study results; or
For any reason is judged by the Investigator to be inappropriate for study participation, including an inability to communicate or cooperate with the Investigator.
Hematopoietic growth factors (i.e., such as erythropoietin or darbepoetin alpha, filgrastim [granulocyte colony-stimulating factor {G-CSF }], sargramostim [granulocyte-macrophage colony-stimulating factor {GM-CSF}], or other thrombopoietic agents) and corticosteroids within 14 days of study entry.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21287
M.D. Anderson Cancer Center
Houston, Texas, 77030
Weill Cornell/New York Presbyterian Hospital
New York, New York, 10021
Contact Kyowa
Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of KW-2449 in Acute Leukemias (AML), Myelodysplastic Syndromes (MDS), and Chronic Myelogenous Leukemia (CML)

Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in subjects with AML, ALL, MDS and CML.

Read the detailed description

This is a Phase I open-label dose escalation study of KW-2449 in subjects with acute leukemias, high risk MDS, and CML who are not candidates for approved therapy. Over an 18-month period, the investigative sites collectively will enroll up to a total of 96 subjects. Subjects will be enrolled sequentially into 1 of 7 dose groups to evaluate 2 dosing schedules (Arm A = 14 consecutive days of dosing followed by a 7-28 day rest period as determined by recovery from any acute hematologic and non-hematologic toxicities, or Arm B = 28 consecutive days of dosing followed by a 7-28 day rest period, as determined by recovery from any acute hematologic and non-hematologic toxicities). The safety of a dose level in Arm A (14-day dosing regimen) will be established prior to enrollment of subjects in the same dose level in Arm B (28-day dosing regimen).

In April 2007 the protocol was amended to discontinue Arm B (28 consecutive days of dosing). The protocol will continue as planned for Arm A (14 days of consecutive dosing).

Enrollment will proceed until a maximum tolerated dose (MTD) has been established for each study Arm. Once the MTD has been reached, 12 additional subjects, with 1 or more of the hematologic conditions included in this study, may be enrolled at the MTD as an expanded safety cohort.

Conditions: Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia
Being tested: KW-2449
Keywords: AML, ALL, MDS, CML, Kinase Inhibitor
Medical subject headings: Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KW-2449Drug
Sequential ascending oral doses of KW-2449 given for 14 or 28 days (modified by protocol amendment to only 14 days dosing).

Study groups in NCT00346632
Study group	Role	What they receive
KW-2449	Experimental	Treatment with ascending doses of KW-2449 Receives: Drug: KW-2449

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0
In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.
Measured: Baseline up to Cycle 2, Day 1

Secondary outcomes (6)

Observed Peak Plasma Concentration (Cmax)
Measured: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1
Time to Peak Plasma Concentration (Tmax)
Measured: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1
Area Under the Plasma Concentration-time Curve From 0 to Tau (AUC (0-tau, Tau is the Dosing Interval))
Measured: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1
Terminal Half Life (t 1/2)
Measured: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1
Accumulation Ratio (AUC 0-tau Day 14 or 28 / AUC 0-tau Day 1)
Measured: Day 1 and either Day 14 or Day 28 of Cycle 1
Disease Response
Disease response (i.e., complete or partial remission) based on standard criteria:
Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-4649.
Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, et al. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-3674.
VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. Criteria for use of Imatinib Mesylate (Gleevec®) [updated March 2002; cited 2005 Nov 16]. Available from: http://www.pbm.va.gov/archive/imatinibcriteria.pdf
Measured: Day 14 (Arm A) or Day 28 (Arm B) for all cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Apr 2008

First posted30 Jun 2006 (estimated)
Study startJun 2006
Primary completionApr 2008
Study completionApr 2008

Why it stopped: Terminated due to suboptimal dosing schedule

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00346632
Sponsor's protocol ID: 2449-US-001
Status last verified: Apr 2024
First submitted: 28 Jun 2006
Last updated: 17 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Pratz KW, Cortes J, Roboz GJ, Rao N, Arowojolu O, Stine A, Shiotsu Y, Shudo A, Akinaga S, Small D, Karp JE, Levis M. A pharmacodynamic study of the FLT3 inhibitor KW-2449 yields insight into the basis for clinical response. Blood. 2009 Apr 23;113(17):3938-46. doi: 10.1182/blood-2008-09-177030. Epub 2008 Nov 24.
PubMed 19029442

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Myelogenous Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of KW-2449 in Acute Leukemias (AML), Myelodysplastic Syndromes (MDS), and Chronic Myelogenous Leukemia (CML)
ClinicalTrials.gov ID: NCT00346632
Acronym / sponsor ID: 2449-US-001
Conditions: Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia
Keywords: AML, ALL, MDS, CML, Kinase Inhibitor
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to suboptimal dosing schedule
Enrolment: 37 participants (actual)
Lead sponsor: Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 30 Jun 2006 (estimated)
Results: Posted 12 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in subjects with AML, ALL, MDS and CML.

Detailed description

In April 2007 the protocol was amended to discontinue Arm B (28 consecutive days of dosing). The protocol will continue as planned for Arm A (14 days of consecutive dosing).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
KW-2449	Experimental	Drug: KW-2449Treatment with ascending doses of KW-2449

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Histologically confirmed diagnosis of:
ECOG Performance Status score of 0, 1, or 2;
Male or female, at least 18 years of age;
Signed written informed consent;
Serum creatinine ≤ 2.0 mg/dL;

Key exclusion criteria (20 listed)

Candidates for approved therapies;
Concomitant treatment with any investigational agent, chemotherapy, radiotherapy, or immunotherapy;
Active CNS leukemia;
Previous or concurrent malignancy except noninvasive non-melanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 2 years prior to study entry;
Uncontrolled systemic infection (viral, bacterial, or fungal);

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
KW-2449Sequential ascending oral doses of KW-2449 given for 14 or 28 days (modified by protocol amendment to only 14 days dosing).	Drug	KW-2449

Primary outcome

Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0
Time frame: Baseline up to Cycle 2, Day 1
In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.

6 secondary outcomes

Observed Peak Plasma Concentration (Cmax)
Time frame: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1
Time to Peak Plasma Concentration (Tmax)
Time frame: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1
Area Under the Plasma Concentration-time Curve From 0 to Tau (AUC (0-tau, Tau is the Dosing Interval))
Time frame: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1
Terminal Half Life (t 1/2)
Time frame: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1
Accumulation Ratio (AUC 0-tau Day 14 or 28 / AUC 0-tau Day 1)
Time frame: Day 1 and either Day 14 or Day 28 of Cycle 1
Disease Response
Time frame: Day 14 (Arm A) or Day 28 (Arm B) for all cycles

Results and safety

Results posted to the registry on 12 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
25 mg/Day KW-2449 14-day Regimen (Arm A)	3	0
50 mg/Day KW-2449 14-day Regimen (Arm A)	3	0
100 mg/Day KW-2449 14-day Regimen (Arm A)	6	0
200 mg/Day KW-2449 14-day Regimen (Arm A)	3	0
300 mg/Day KW-2449 14-day Regimen (Arm A)	4	0
400 mg/Day KW-2449 14-day Regimen (Arm A)	2	0
500 mg/Day KW-2449 14-day Regimen (Arm A)	5	0
25 mg/Day KW-2449 28-day Regimen (Arm B)	4	0
50 mg/Day KW-2449 28-day Regimen (Arm B)	4	0
100 mg/Day KW-2449 28-day Regimen (Arm B)	3	0

Primary outcome: Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0

Time frame: Baseline up to Cycle 2, Day 1. Number. Unit: participants

Measure	Arm A - 25 mg/Day n = 3	Arm A - 50 mg/Day n = 3	Arm A - 100 mg/Day n = 6	Arm A - 200 mg/Day n = 3	Arm A - 300 mg/Day n = 4	Arm A - 400 mg/Day n = 2	Arm A - 500 mg/Day n = 5	Arm A - Total n = 26	Arm B - 25 mg/Day n = 4	Arm B - 50 mg/Day n = 4	Arm B - 100 mg/Day n = 3	Arm B - Total n = 11
Subjects with any TEAE	3	3	6	3	4	2	5	26	4	4	3	11
Subjects with any serious TEAE	2	2	5	2	4	1	3	19	2	3	3	8
Subjects with TEAE related to study drug	1	3	6	3	4	2	3	22	3	3	3	9
Subjects with TEAE of Grade 3 or above	2	2	6	2	4	2	3	21	1	3	3	7
Subjects who discontinued the study due to TEA	0	0	0	0	0	0	0	0	0	0	0	0
Subjects who died	1	0	5	1	3	0	1	11	0	1	0	1

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A - 25 mg/Day	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Arm A - 50 mg/Day	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Arm A - 100 mg/Day	5 of 6 (83.3%)	6 of 6 (100%)	Not reported
Arm A - 200 mg/Day	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Arm A - 300 mg/Day	4 of 4 (100%)	4 of 4 (100%)	Not reported
Arm A - 400 mg/Day	1 of 2 (50%)	2 of 2 (100%)	Not reported
Arm A - 500 mg/Day	3 of 5 (60%)	5 of 5 (100%)	Not reported
Arm A - Total	19 of 26 (73.1%)	26 of 26 (100%)	Not reported
Arm B - 25 mg/Day	2 of 4 (50%)	4 of 4 (100%)	Not reported
Arm B - 50 mg/Day	3 of 4 (75%)	4 of 4 (100%)	Not reported
Arm B - 100 mg/Day	3 of 3 (100%)	3 of 3 (100%)	Not reported
Arm B - Total	8 of 11 (72.7%)	11 of 11 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19029442Pratz KW, Cortes J, Roboz GJ, Rao N, Arowojolu O, Stine A, Shiotsu Y, Shudo A, Akinaga S, Small D, Karp JE, Levis M. A pharmacodynamic study of the FLT3 inhibitor KW-2449 yields insight into the basis for clinical response. Blood. 2009 Apr 23;113(17):3938-46. doi: 10.1182/blood-2008-09-177030. Epub 2008 Nov 24.
Individual participant dataSharing planned: Undecided

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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.

Matt Fujimori, MD study director

Kyowa Kirin, Inc.

4 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 KW-2449 in people with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia, run by Kyowa Kirin, Inc. at 4 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 11 inclusion and 20 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 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Yes. Results are posted in the registry (first posted 12 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0 (time frame: Baseline up to Cycle 2, Day 1). 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 NCT00346632, 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 17 May 2024.