Trial · NCT01218477
Dasatinib Combination Therapy With the Smoothened (SMO) Inhibitor BMS-833923 in Chronic Myeloid Leukemia (CML)
NCT01218477, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2014-05-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Dasatinib Combination Therapy With the Smoothened (SMO) Inhibitor BMS-833923 in Chronic Myeloid Leukemia (CML). Trials, record NCT01218477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218477
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib Combination Therapy With the Smoothened (SMO) Inhibitor BMS-833923 in Chronic Myeloid Leukemia (CML)
- NCT number
- NCT01218477
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia
- Interventions
- Dasatinib, BMS-833923
- First posted
- 2010-10-11
- Last updated
- 2016-06-17
- Other registries' IDs
- eudract:2010-019480-11
- Results first posted
- 2014-05-20
- Limitations and caveats
- Bristol-Myers Squibb discontinued research in the area of smoothened inhibitors. This study was completed early and limited efficacy data was published in a synoptic clinical study report .
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose (RP2D) of BMS-833923 Plus Dasatinib in Chronic Myeloid Leukemia-Chronic Phase | Day 1 to Week 80, with observation for DLT in Weeks 5-8 | The following drug-related adverse events (AEs) occurring in the first 28 days of treatment were considered dose-limiting toxicities (DLT): Grade 4 hematologic AE lasting \>7 days; ≥Grade 3 nonhematologic AE, despite medical intervention; ≥Grade 2 AE uncontrolled by medical intervention and requiring treatment interruption for \>7 days. RP2D was that dose at which ≤1 of 6 patients had a DLT in the first 4 weeks of treatment. If \<3 patients were DLT-evaluable, up to 6 additional patients entered the same dose level. Accrual to a dose level closed if 6 patients were enrolled and \<3 were DLT-evaluable. If ≥3 patients at a dose level had no DLTs when a new patient enrolled, the dose was escalated to next level. If 1 DLT was observed in \<6 patients, ≥6 patients were required; if no additional DLT was observed, the dose was escalated to the next highest level. If ≥2 DLTs were observed in \<6 patients, that level exceeded the RP2D, and the dose was deescalated to the next lowest level. |
| Secondary | Percentage of Participants With a Major Cytogenetic Response (MCyR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Day 1 to Week 80 | Cytogenetic response (CyR) was based on the proportion of Philadelphia chromosome-positive (Ph+) cells in metaphase analysis of bone marrow. Complete cytogenetic response (CCyR)=0 Ph+ cells; Partial CyR (PCyR)=1 to 35 Ph+ cells; Minor CyCR= 36-65 Ph+ cells; Minimal CyCR= 66-95 Ph+ cells; No response= \>96 Ph+ cells. MCyR=CCyR + PCyR. Nilo=nilotinib; SOR=suboptimal response. |
| Secondary | Percentage of Participants With a Major Hematologic Response (MHR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Day 1 to Week 80 | MHR was defined as complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR for CML-Adv criteria: white blood cell count (WBC) ≤upper limit normal; absolute neutrophil count (ANC) ≥1,000/mm\^3; platelets ≥100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); basophils \<5% in PB; myelocytes + metamyelocytes \< 5% in PB; no extramedullary involvement; blasts must be \<5%, if bone marrow assessment (BMA) performed. NEL had same criteria, but with lower thresholds for reconstitution of PB counts, as follows: Platelets ≥ 20,000/mm\^3 or ANC \>500/mm\^3. Confirmed MHR obtained if these criteria met and maintained for ≥28 days. CHR for CML-CP criteria WBC ≤10,000/mm\^3; platelets \<450,000/mm\^3; basophils \<5% in PB; no blasts or promyelocytes in PB; myelocytes + metamyelocytes \<5% in PB; no extramedullary involvement; blasts must be \<5% if BMA performed. Confirmed CHR obtained if these criteria met and maintained for ≥28 days. Nilo=nilotinib; SOR=suboptimal response. |
| Secondary | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, at Least 1 Drug-related AE, and Dose-limiting Toxicities | Day 1 to Week 80, continuously, with observation for dose-limiting toxicities (DLTs) in Weeks 5-8 | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment and may or may not be related to treatment. SAE=an untoward 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. The following drug-related AEs occurring during the first 28 days of treatment with both agents were considered to be dose-limiting toxicities (DLTs): Grade 4 hematologic AE lasting \>7 days; ≥Grade 3 nonhematologic AE, despite adequate medical intervention; ≥Grade 2 AE not controlled by medical intervention and requiring treatment interruption for \>7 days. |
| Secondary | Number of Participants With Grade 3-4 Abnormalities on Laboratory Test Results | Day 1 to Week 80 | ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria of the National Cancer Institute from 1 (least severe) to 4 (life threatening). ANC (\*10\^9): Grade 3, \<1.0- 0.5; Grade 4, \<0.5. Hemoglobin (mmol/L): Grade 3, \<4.9-4.0; Grade 4, \<4.0. Platelet count (\*10\^9/L): Grade 3, \<50.0-25.0; Grade 4, \<25. WBCs (\*10\^9): Grade 3, \<2.0-1.0; Grade 4, \<1.0. Hypocalcemia (mmol/L): Grade 3, \<1.75-1.5; Grade 4, \<1.5. Hyperkalemia (mmol/L): Grade 3, \>6.0-7.0; Grade 4, \>7.0. Hypokalemia (mmol/L): Grade 3, \<3.0-2.5; Grade 4, \<2.5. Hyponatremia (mmol/L), Grade 3, \<130-120; Grade 4, \<120. Hypermagnesemia (mg/dL): Grade 3, \>1.23-3.30; Grade 4, \>3.30. Phosphorus (mmol/L): Grade 3, \<0.6-0.3; Grade 4, \<0.3. Lipase (\*ULN): Grade 3, \>2.0-5.0; Grade 4, \>5.0. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Phase 2 Dose (RP2D) of BMS-833923 Plus Dasatinib in Chronic Myeloid Leukemia-Chronic Phase | Day 1 to Week 80, with observation for DLT in Weeks 5-8 | Participants who were dose-limiting toxicity (DLT)-evaluable (DLT-evaluable=received combination therapy on \>21 of 28 days in Weeks 5 through 8 or interrupted treatment for drug-related AEs) | mg | NUMBER |
| SECONDARY | Percentage of Participants With a Major Cytogenetic Response (MCyR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Day 1 to Week 80 | All patients without CCyR at dosing start date who received at least 4 weeks of dasatinib and had at least 1 on-treatment cytogenetic evaluation of the bone marrow data after at least 4 weeks on treatment | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Major Hematologic Response (MHR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Day 1 to Week 80 | Patients without complete hematologic response at dosing start date who received at least 4 weeks of dasatinib and who had at least 1 on-treatment evaluation of both peripheral blood counts and bone marrow cytogenetic response after at least 4 weeks on treatment. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, at Least 1 Drug-related AE, and Dose-limiting Toxicities | Day 1 to Week 80, continuously, with observation for dose-limiting toxicities (DLTs) in Weeks 5-8 | All participants who received at least 1 dose of study drug | Participants | NUMBER |
| SECONDARY | Number of Participants With Grade 3-4 Abnormalities on Laboratory Test Results | Day 1 to Week 80 | All participants who received at least 1 dose of study drug. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group79
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Phase 2 Dose (RP2D) of BMS-833923 Plus Dasatinib in Chronic Myeloid Leukemia-Chronic Phase | Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD | 50 | mg | ||
| Percentage of Participants With a Major Cytogenetic Response (MCyR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD | CML-CP with imatinib or nilo resistance/SOR (n=6) | 66.7 | 95% Confidence Interval 22.28 to 95.67 | Percentage of participants |
| Percentage of Participants With a Major Cytogenetic Response (MCyR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD | CML-CP with dasatinib resistance/SOR (n=10) | 20 | 95% Confidence Interval 2.52 to 55.61 | Percentage of participants |
| Percentage of Participants With a Major Cytogenetic Response (MCyR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD | CML-Adv with imatinib or nilo resistance/SOR (n=3) | 66.7 | 95% Confidence Interval 9.43 to 99.16 | Percentage of participants |
| Percentage of Participants With a Major Hematologic Response (MHR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD | CML-CP with imatinib or nilo resistance/SOR (n=2) | 50 | 95% Confidence Interval 1.26 to 98.74 | Percentage of participants |
| Percentage of Participants With a Major Hematologic Response (MHR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD | CML-CP with dasatinib resistance/SOR (n=5) | 60 | 95% Confidence Interval 14.66 to 94.73 | Percentage of participants |
| Percentage of Participants With a Major Hematologic Response (MHR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP) | Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD | CML-CP with imatinib or nilo resistance/SOR (n=1) | 100 | 95% Confidence Interval 2.5 to 100 | Percentage of participants |
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, at Least 1 Drug-related AE, and Dose-limiting Toxicities | Dasatinib, 100/140 mg QD | Death | 1 | Participants | |
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, at Least 1 Drug-related AE, and Dose-limiting Toxicities | Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD | Death | 0 | Participants | |
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, at Least 1 Drug-related AE, and Dose-limiting Toxicities | Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD | Death | 2 | Participants |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib, 100/140 mg QD | 3 | |
| Overall Study | STARTED | Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD | 8 | |
| Overall Study | STARTED | Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD | 14 | |
| Overall Study | STARTED | Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD | 2 | |
| Overall Study | COMPLETED | Dasatinib, 100/140 mg QD | 0 | |
| Overall Study | COMPLETED | Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD | 0 | |
| Overall Study | COMPLETED | Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD | 0 | |
| Overall Study | COMPLETED | Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib, 100/140 mg QD | 3 | |
| Overall Study | NOT COMPLETED | Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events524
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 | Acne | Skin and subcutaneous tissue disorders | Dasatinib, 100/140 mg QD | 0 | 3 | |
| other | Acne | Skin and subcutaneous tissue disorders | Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD | 2 | 8 | |
| other | Acne | Skin and subcutaneous tissue disorders | Dasatanib, 100/140 mg QD + BMS-833923, 100 mg BID/QD | 0 | 14 | |
| other | Acne | Skin and subcutaneous tissue disorders | Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD | 0 | 2 | |
| other | Amylase | Investigations | Dasatinib, 100/140 mg QD | 0 | 3 | |
| other | Amylase | Investigations | Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD | 2 | 8 | |
| other | Amylase | Investigations | Dasatanib, 100/140 mg QD + BMS-833923, 100 mg BID/QD | 0 | 14 | |
| other | Amylase | Investigations | Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD | 0 | 2 | |
| other | Amylase increased | Investigations | Dasatinib, 100/140 mg QD | 0 | 3 | |
| other | Amylase increased | Investigations | Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD | 2 | 8 |
1 to 10 of 524Source ClinicalTrials.gov
See all 524 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib, 100/140 mg QD | ||
| Total, all-cause mortality | Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD | ||
| Total, all-cause mortality | Dasatanib, 100/140 mg QD + BMS-833923, 100 mg BID/QD | ||
| Total, all-cause mortality | Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD | ||
| Total, other adverse events | Dasatinib, 100/140 mg QD | 0 | 3 |
| Total, other adverse events | Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD | 8 | 8 |
| Total, other adverse events | Dasatanib, 100/140 mg QD + BMS-833923, 100 mg BID/QD | 14 | 14 |
| Total, other adverse events | Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD | 2 | 2 |
| Total, serious adverse events | Dasatinib, 100/140 mg QD | 1 | 3 |
| Total, serious adverse events | Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD | 3 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01218477
GET https://conductscience.org/api/trials/v1/NCT01218477/results?page=2