Chronic Myelogenous LeukemiaPhase 1/2NCT00337454
Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
A Phase 1/2 study testing Dasatinib in people with Chronic Myelogenous Leukemia, run by Bristol-Myers Squibb at 21 sites in Japan.
Trial summary
This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 21 sitesJapan
- Study dates
- Jul 2005to Mar 2007
- 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 20 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Philadelphia chromosome positive or bcr-abl gene positive
- Chronic Myelogenous Leukemia (CML)
- Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
- Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
- Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
- Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
- Men and women, ages 20 - 75
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
Who cannot join
- Subjects who are eligible and willing to undergo transplantation at pre-study
- Women who are pregnant or breastfeeding
- Uncontrolled or significant cardiovascular disease
- History of significant bleeding disorder unrelated to CML or ALL
- Adequate hepatic function
- Adequate renal function
Show all 9Show fewer
- Medication that increase bleeding risk
- Medication that change heart rhythms
- Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
Local Institution
Bunkyo-Ku, Tokyo, 113-8677
Local Institution
Chuo-Ku, Tokyo, 104-0045
Local Institution
Hamamatsu, Shizuoka, 431-3192
Local Institution
Iruma-Gun, Saitama, 350-0495
Local Institution
Isehara-Shi, Kanagawa, 259-1193
Local Institution
Kagoshima, Kagoshima-ken, 890-0064
Local Institution
Kanagawa, Kanagawa
Local Institution
Kyoto, Kyoto
Local Institution
Maebashi, Gunma, 371-0821
Local Institution
Moriguchi, Osaka, 570-8540
Local Institution
Nagasaki, Nagasaki
Local Institution
Nagoya, Aichi-ken, 464-8681
Local Institution
Nagoya, Aichi-ken, 466-8550
Local Institution
Nagoya, Aichi-ken, 467-8602
Local Institution
Nishinomiya-Shi, Hyōgo, 663-8501
Local Institution
Okayama, Okayama-ken, 700-0082
Local Institution
Sendai, Miyagi
Local Institution
Shinjuku-Ku, Tokyo, 160-8582
Local Institution
Shinjuku-Ku, Tokyo, 162-8666
Local Institution
Tochigi, Tochigi, 329-0498
Local Institution
Tokyo, Tokyo
About this study
Official title: A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment
This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- Dasatinib
- Keywords
- Imatinib resistant or intolerant CML, Treatment resistant or intolerant Ph+ALL
- Medical subject headings
- 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.
DasatinibDrug
Also called Sprycel
Tablets, Oral, 50mg BID, once daily, 24 weeks.
DasatinibDrug
Also called Sprycel
Tablets, Oral, 70mg BID, once daily, 24 weeks.
DasatinibDrug
Also called Sprycel
Tablets, Oral, 90mg BID, once daily, 24 weeks.
DasatinibDrug
Also called Sprycel
Tablets, Oral, 70mg BID, once daily, 24 weeks.
DasatinibDrug
Also called Sprycel
Tablets, Oral, 70mg BID, once daily, 12 weeks.
DasatinibDrug
Also called Sprycel
Tablets, Oral, 70mg BID, once daily, 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: Dasatinib |
| A2 | Experimental | Not described Receives: Drug: Dasatinib |
| A3 | Experimental | Not described Receives: Drug: Dasatinib |
| B1 | Experimental | Not described Receives: Drug: Dasatinib |
| B2 | Experimental | Not described Receives: Drug: Dasatinib |
| B3 | Experimental | Not described Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response
Secondary outcomes (2)
Pharmacokinetic profiles, cytogenetic response and hematologic response, BCR-ABL point mutations and biochemical assays of BCR-ABL, safety, time to and duration of hematologic and cytogenetic response
response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJul 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337454
- Sponsor's protocol ID
- CA180-031
- Status last verified
- Apr 2011
- First submitted
- 14 Jun 2006
- Last updated
- 14 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment
- ClinicalTrials.gov ID
- NCT00337454
- Acronym / sponsor ID
- CA180-031
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- Imatinib resistant or intolerant CML, Treatment resistant or intolerant Ph+ALL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Jun 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.
This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Dasatinib |
| A2 | Experimental | Drug: Dasatinib |
| A3 | Experimental | Drug: Dasatinib |
| B1 | Experimental | Drug: Dasatinib |
| B2 | Experimental | Drug: Dasatinib |
| B3 | Experimental | Drug: Dasatinib |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Philadelphia chromosome positive or bcr-abl gene positive
- Chronic Myelogenous Leukemia (CML)
- Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
- Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
- Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
Key exclusion criteria (9 listed)
- Subjects who are eligible and willing to undergo transplantation at pre-study
- Women who are pregnant or breastfeeding
- Uncontrolled or significant cardiovascular disease
- History of significant bleeding disorder unrelated to CML or ALL
- Adequate hepatic function
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 |
|---|---|---|
| DasatinibAlso: SprycelTablets, Oral, 50mg BID, once daily, 24 weeks. | Drug | A1 |
| DasatinibAlso: SprycelTablets, Oral, 70mg BID, once daily, 24 weeks. | Drug | A2 |
| DasatinibAlso: SprycelTablets, Oral, 90mg BID, once daily, 24 weeks. | Drug | A3 |
| DasatinibAlso: SprycelTablets, Oral, 70mg BID, once daily, 24 weeks. | Drug | B1 |
| DasatinibAlso: SprycelTablets, Oral, 70mg BID, once daily, 12 weeks. | Drug | B2 |
| DasatinibAlso: SprycelTablets, Oral, 70mg BID, once daily, 12 weeks. | Drug | B3 |
Primary outcome
Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response
2 secondary outcomes
Pharmacokinetic profiles, cytogenetic response and hematologic response, BCR-ABL point mutations and biochemical assays of BCR-ABL, safety, time to and duration of hematologic and cytogenetic response
response
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 14 Apr 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dasatinib in people with Chronic Myelogenous Leukemia, run by Bristol-Myers Squibb at 21 sites in Japan.
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 8 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 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan. 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 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 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?
Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response. 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 14 Apr 2011.