Trial · NCT01357655
Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)
NCT01357655, Phase 2, Terminated, Bristol-Myers Squibb; results first posted 2017-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923). Trials, record NCT01357655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01357655
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)
- NCT number
- NCT01357655
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia
- Interventions
- Dasatinib, BMS-833923
- First posted
- 2011-05-23
- Last updated
- 2017-03-14
- Other registries' IDs
- eudract:2011-000083-10
- Results first posted
- 2017-03-14
- Limitations and caveats
No recommended phase 2 dose of the SMO antagonist was determined (in a separate trial). It was decided to discontinue enrollment and end this trial early. The decision was not made due to any new safety signals for dasatinib or the SMO antagonist.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Major Molecular Response | 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. |
| Secondary | Complete Molecular Response at Any Time | Baseline to End of study (approximately 48 months) | |
| Secondary | Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death | Baseline to End of study (approximately 48 months) | |
| Secondary | Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation | Baseline to End of study (approximately 48 months) | |
| Secondary | Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death | Baseline to End of study (approximately 48 months) | |
| Secondary | Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death | From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Major Molecular Response | Baseline up to 12 months | Efficacy Sample: all treated participants with at least one assessment on treatment. Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Molecular Response at Any Time | Baseline to End of study (approximately 48 months) | The study was terminated prior to data collection for this endpoint. | ||
| SECONDARY | Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death | Baseline to End of study (approximately 48 months) | The study was terminated prior to data collection for this endpoint. | ||
| SECONDARY | Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation | Baseline to End of study (approximately 48 months) | The study was terminated prior to data collection for this endpoint. | ||
| SECONDARY | Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death | Baseline to End of study (approximately 48 months) | The study was terminated prior to data collection for this endpoint. | ||
| SECONDARY | Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death | From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months) | All Treated Participants; Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Major Molecular Response | Dasatinib | Baseline | 1 | Participants | |
| Number of Participants With Major Molecular Response | Dasatinib + SMO Antagonist (BMS-833923) | Baseline | 0 | Participants | |
| Number of Participants With Major Molecular Response | Dasatinib | 3 Months | 9 | Participants | |
| Number of Participants With Major Molecular Response | Dasatinib + SMO Antagonist (BMS-833923) | 3 Months | 0 | Participants | |
| Number of Participants With Major Molecular Response | Dasatinib | 6 Months | 30 | Participants | |
| Number of Participants With Major Molecular Response | Dasatinib + SMO Antagonist (BMS-833923) | 6 Months | 0 | Participants | |
| Number of Participants With Major Molecular Response | Dasatinib | 12 Months | 34 | Participants | |
| Number of Participants With Major Molecular Response | Dasatinib + SMO Antagonist (BMS-833923) | 12 Months | 0 | Participants | |
| Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death | Dasatinib | SAE | 18 | participants | |
| Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death | Dasatinib | Drug-Related AE | 56 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib | 66 | |
| Overall Study | STARTED | Dasatinib + SMO Antagonist (BMS-833923) | 0 | |
| Overall Study | COMPLETED | Dasatinib | 0 | |
| Overall Study | COMPLETED | Dasatinib + SMO Antagonist (BMS-833923) | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib | 66 | |
| Overall Study | NOT COMPLETED | Dasatinib + SMO Antagonist (BMS-833923) | 0 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chest pain | General disorders | Dasatinib | 6 | 66 | |
| other | Fatigue | General disorders | Dasatinib | 8 | 66 | |
| other | Nasopharyngitis | Infections and infestations | Dasatinib | 5 | 66 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Dasatinib | 7 | 66 | |
| other | Anxiety | Psychiatric disorders | Dasatinib | 4 | 66 | |
| other | Hypertension | Vascular disorders | Dasatinib | 7 | 66 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Dasatinib | 6 | 66 | |
| other | Pharyngitis | Infections and infestations | Dasatinib | 4 | 66 | |
| other | Vomiting | Gastrointestinal disorders | Dasatinib | 13 | 66 | |
| other | Constipation | Gastrointestinal disorders | Dasatinib | 4 | 66 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | 2 | 66 |
| Total, other adverse events | Dasatinib | 60 | 66 |
| Total, serious adverse events | Dasatinib | 18 | 66 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01357655
GET https://conductscience.org/api/trials/v1/NCT01357655/events?page=2