LeukemiaPhase 2NCT01357655
Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)
A Phase 2 study testing Dasatinib and BMS-833923 in people with Leukemia, run by Bristol-Myers Squibb at 24 sites in 8 countries.
Trial summary
The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Dasatinib and BMS-833923
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 24 sitesin 8 countries
- Study dates
- Sep 2011to Jan 2016
- Phase
- Phase 2
- 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
- Subjects ≥ 18 years of age who have signed informed consent
- Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase
- Previously untreated chronic phase CML, except for Anagrelide or Hydroxyurea.
- Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2
Who cannot join
- Known Abl-kinase T315I or T315A mutation
- Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition
- Prior chemotherapy.
- Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period.
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
France7 sites
Local Institution
Bordeaux, 33076
Local Institution
Le Chesnay, 78150
Local Institution
Lille, 59037
Local Institution
Nantes, Cedex, 44000
Local Institution
Paris, 75475
Local Institution
Strasbourg, 67091
Local Institution
Toulouse, 31059
Poland5 sites
Local Institution
Chorzów, 41-500
Local Institution
Gdansk, 80-952
Local Institution
Krakow, 30-510
Local Institution
Lodz, 93-513
Local Institution
Wroc#aw, 50-367
Spain4 sites
Local Institution
Madrid, 28006
Local Institution
Madrid, 28034
Local Institution
Oviedo, 33006
Local Institution
Pamplona, 31008
United States3 sites
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Tennessee Oncology Pllc
Nashville, Tennessee, 37203
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Belgium2 sites
Local Institution
Antwerp, 2060
Local Institution
Bruges, B-8000
Argentina1 site
Local Institution
San Miguel de Tucumán, Tucumán Province, 4000
About this study
Official title: An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).
The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.
Read the detailed description
- Design: Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor. Subjects currently enrolled in the trial will continue to receive dasatinib alone at a starting dose of 100 mg QD for:
- a maximum of 5 years after entry into the study
- until progression by Investigators determination/judgment
- intolerance to Dasatinib
- the study is terminated due to safety concerns or
- other administrative reasons as communicated by the sponsor
- Research Hypothesis :
The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor. The objective of the altered design of this study is to describe the safety profile and tolerability of dasatinib
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, 100 mg, Once daily, approximately 5 years depending on response
BMS-833923Drug
Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Dasatinib | Active comparator | Not described Receives: Drug: Dasatinib |
| Arm2: Dasatinib + BMS-833923 | Experimental | Dasatinib for 1 year followed by dasatinib plus BMS-833923 for 2 years followed by dasatinib alone for approximately 2 years; depending on response Receives: Drug: Dasatinib; Drug: BMS-833923 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Molecular Response
Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.
Measured: Baseline up to 12 months
Secondary outcomes (5)
Complete Molecular Response at Any Time
Measured: Baseline to End of study (approximately 48 months)
Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death
Measured: Baseline to End of study (approximately 48 months)
Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation
Measured: Baseline to End of study (approximately 48 months)
Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death
Measured: Baseline to End of study (approximately 48 months)
Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug.
Measured: From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: No participants enrolled in this trial could receive the SMO antagonist as a recommended phase 2 dose was not determined by a different, concurrently-run trial.
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.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357655
- Sponsor's protocol ID
- CA180-363
- Other IDs
- 2011-000083-10
- Status last verified
- Jan 2017
- First submitted
- 18 May 2011
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).
- ClinicalTrials.gov ID
- NCT01357655
- Acronym / sponsor ID
- CA180-363
- Conditions
- Leukemia
- Keywords
- Myelogenous, Chronic, BCR-ABL Positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No participants enrolled in this trial could receive the SMO antagonist as a recommended phase 2 dose was not determined by a different, concurrently-run trial.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Posted 14 Mar 2017
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 the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.
Detailed description
- Design: Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor. Subjects currently enrolled in the trial will continue to receive dasatinib alone at a starting dose of 100 mg QD for:
- a maximum of 5 years after entry into the study
- until progression by Investigators determination/judgment
- intolerance to Dasatinib
- the study is terminated due to safety concerns or
- other administrative reasons as communicated by the sponsor
- Research Hypothesis :
The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor. The objective of the altered design of this study is to describe the safety profile and tolerability of dasatinib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Dasatinib | Active comparator | Drug: Dasatinib |
| Arm2: Dasatinib + BMS-833923 | Experimental | Drug: Dasatinib, Drug: BMS-833923Dasatinib for 1 year followed by dasatinib plus BMS-833923 for 2 years followed by dasatinib alone for approximately 2 years; depending on response |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects ≥ 18 years of age who have signed informed consent
- Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase
- Previously untreated chronic phase CML, except for Anagrelide or Hydroxyurea.
- Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2
Key exclusion criteria (4 listed)
- Known Abl-kinase T315I or T315A mutation
- Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition
- Prior chemotherapy.
- Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period.
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: Sprycel®Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response | Drug | Arm 1: Dasatinib, Arm2: Dasatinib + BMS-833923 |
| BMS-833923Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response | Drug | Arm2: Dasatinib + BMS-833923 |
Primary outcome
Number of Participants With Major Molecular Response
Time frame: Baseline up to 12 months
Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.
5 secondary outcomes
Complete Molecular Response at Any Time
Time frame: Baseline to End of study (approximately 48 months)
Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death
Time frame: Baseline to End of study (approximately 48 months)
Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation
Time frame: Baseline to End of study (approximately 48 months)
Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death
Time frame: Baseline to End of study (approximately 48 months)
Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death
Time frame: From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib and BMS-833923 in people with Leukemia, run by Bristol-Myers Squibb at 24 sites in 8 countries.
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 4 inclusion and 4 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, Poland, Spain, United States, Belgium and 3 more countries. 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 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?
Yes. Results are posted in the registry (first posted 14 Mar 2017). 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?
Number of Participants With Major Molecular Response (time frame: Baseline up to 12 months). 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 Mar 2017.