Leukemia, MyeloidPhase 2NCT00030186
Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
A Phase 2 study testing CEP-701 60mg, Cep-701 80mg and Cep-701 40mg in people with Leukemia, Myeloid, run by Cephalon.
Trial summary
The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid
- What is being tested?
- CEP-701 60mg, Cep-701 80mg and Cep-701 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Feb 2003
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient must have confirmed diagnosis of refractory or relapsed AML that expresses a FLT-3 mutation
- patient must have life expectancy of more than 2 months
- patient must be fully recovered from reversible side effects of previous therapy for cancer
Who cannot join
- total bilirubin, ALT or AST greater than 2 times upper limit of normal
- patient <65 years of age with estimated creatinine clearance less than 60 mL/min; patient >65 years of age with serum creatinine > 1.5 times the upper limit of normal (ULN)
- received any investigational drug within past 4 weeks
- GI disturbance/malabsorption that may affect absorption of CEP-701
- HIV positive
- received NSAID within prior 14 days
- has active infection
About this study
Official title: An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations
The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.
Read the detailed description
This is an open-label study of CEP-701 in patients with refractory, relapsed, or poor risk AML expressing FLT-3 activating mutations. Patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days (1 cycle). Upon completion of cycle 1, the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day, dependent upon response to 60 mg dosage.
- Conditions
- Leukemia, Myeloid
- Being tested
- CEP-701 60mg, Cep-701 80mg, Cep-701 40mg
- Keywords
- AML, FLT-3 mutation
- Medical subject headings
- Leukemia, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEP-701 60mgDrug
60mg orally 2 times a day for 28 days
Cep-701 80mgDrug
80mg 2 times a day, dependent upon response to cycle 1
Cep-701 40mgDrug
40mg 2 times a day, dependent upon response to cycle 1
| Study group | Role | What they receive |
|---|---|---|
| Cycle 1 | Experimental | 60mg Receives: Drug: CEP-701 60mg |
| Cycle 2 | Experimental | 80mg dependent upon response to Cycle 1 Receives: Drug: Cep-701 80mg |
| Cycle 2b | Experimental | 40mg dependent upon response to Cycle 1 Receives: Drug: Cep-701 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Samples and/or bone marrow assessments for complete remission (CR), complete tumor clearance (CTC), or hematologic response (HR) from bone marrow
Response rate of patients with refactory, relapsed, or poor risk acute myeloid leukemia (AML) expressing Fms-like tyrosine kinase 3 (FLT-3) activating mutations. CR is defined as presence of less than 5% myeloblasts in bone marrow with normalized peripheral blood cell counts. HR is defined as a 50% or more decrease in the absolute number of peripheral blast count or at least a 50% reduction in bone marrow blasts.
Measured: 56 days
Secondary outcomes (3)
Number of days to response
Response as defined by CR, CTC, or HR.
Measured: 56 Days
Number of days to disease progression
Response as defined by CR, CTC, or HR.
Measured: 56 Days
Levels of FLT-3 phosphorylation inhibition in vivo
The degree of inhibition of FLT-3 autophosphorylation measured in ex vivo bioassay plasma samples
Measured: 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2002 (estimated)
- Study startJan 2002
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, MyeloidStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030186
- Sponsor's protocol ID
- C0701a/202/ON/US
- Status last verified
- Aug 2012
- First submitted
- 7 Feb 2002
- Last updated
- 23 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations
- ClinicalTrials.gov ID
- NCT00030186
- Acronym / sponsor ID
- C0701a/202/ON/US
- Conditions
- Leukemia, Myeloid
- Keywords
- AML, FLT-3 mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 8 Feb 2002 (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 determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.
Detailed description
This is an open-label study of CEP-701 in patients with refractory, relapsed, or poor risk AML expressing FLT-3 activating mutations. Patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days (1 cycle). Upon completion of cycle 1, the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day, dependent upon response to 60 mg dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cycle 1 | Experimental | Drug: CEP-701 60mg60mg |
| Cycle 2 | Experimental | Drug: Cep-701 80mg80mg dependent upon response to Cycle 1 |
| Cycle 2b | Experimental | Drug: Cep-701 40mg40mg dependent upon response to Cycle 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient must have confirmed diagnosis of refractory or relapsed AML that expresses a FLT-3 mutation
- patient must have life expectancy of more than 2 months
- patient must be fully recovered from reversible side effects of previous therapy for cancer
Key exclusion criteria (7 listed)
- total bilirubin, ALT or AST greater than 2 times upper limit of normal
- patient <65 years of age with estimated creatinine clearance less than 60 mL/min; patient >65 years of age with serum creatinine > 1.5 times the upper limit of normal (ULN)
- received any investigational drug within past 4 weeks
- GI disturbance/malabsorption that may affect absorption of CEP-701
- HIV positive
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 |
|---|---|---|
| CEP-701 60mg60mg orally 2 times a day for 28 days | Drug | Cycle 1 |
| Cep-701 80mg80mg 2 times a day, dependent upon response to cycle 1 | Drug | Cycle 2 |
| Cep-701 40mg40mg 2 times a day, dependent upon response to cycle 1 | Drug | Cycle 2b |
Primary outcome
Blood Samples and/or bone marrow assessments for complete remission (CR), complete tumor clearance (CTC), or hematologic response (HR) from bone marrow
Time frame: 56 days
Response rate of patients with refactory, relapsed, or poor risk acute myeloid leukemia (AML) expressing Fms-like tyrosine kinase 3 (FLT-3) activating mutations. CR is defined as presence of less than 5% myeloblasts in bone marrow with normalized peripheral blood cell counts. HR is defined as a 50% or more decrease in the absolute number of peripheral blast count or at least a 50% reduction in bone marrow blasts.
3 secondary outcomes
Number of days to response
Time frame: 56 Days
Number of days to disease progression
Time frame: 56 Days
Levels of FLT-3 phosphorylation inhibition in vivo
Time frame: 56 Days
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 23 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CEP-701 60mg, Cep-701 80mg and Cep-701 40mg in people with Leukemia, Myeloid, run by Cephalon.
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 7 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 23 Aug 2012. 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 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?
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?
Blood Samples and/or bone marrow assessments for complete remission (CR), complete tumor clearance (CTC), or hematologic response (HR) from bone marrow (time frame: 56 days). 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 23 Aug 2012.