Trial · NCT01916785
OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)
NCT01916785, Phase 2, Completed, Versailles Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy). Trials, record NCT01916785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01916785
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)
- NCT number
- NCT01916785
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 289 participants, actual
- Lead sponsor
- Versailles Hospital
- Conditions
- Chronic Myelogenous Leukemia, BCR/ABL Positive
- Interventions
- Dasatinib
- First posted
- 2013-08-06
- Last updated
- 2026-07-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative rate of significant AE | 12 months therapy | The cumulative rate of serious AEs defined by grade 3-4 fluid retention, all grade pleural effusion, haematological grade 3-4 AEs related to dasatinib and/or all AE leading to dasatinib discontinuation within the first year of therapy |
| Secondary | Rate of treatment interruptions | 12 months therapy | To compare the rate of treatment interruptions |
| Secondary | Cumulative duration of dasatinib interruption | 12 months therapy | To compare the cumulative duration of dasatinib interruption C. To compare the median dose of dasatinib administered during the first 12 months |
| Secondary | Mean dose of dasatinib | 12 months therapy | To compare the mean dose of dasatinib administered during the first 12 months |
| Secondary | Cumulative rate of complete cytogenetic response | 12 months therapy | To compare the cumulative rate of complete cytogenetic response (CCR) at 6, 12 and 18 months, and every 12 months thereafter |
| Secondary | Cumulative rate of major molecular response | 12 months therapy | To compare the cumulative rate of major molecular response (MMR) at 3, 6, 12, and 18 months, and every 6 months thereafter |
| Secondary | Median dose of dasatinib administered | 12 months therapy | To compare the median dose of dasatinib administered during the first 12 months |
| Secondary | Cumulative rate of complete molecular response | 12 months therapy | To compare the cumulative rate of complete molecular response at 3, 6, 12 and 18 months, and every 6 months thereafter |
| Secondary | Time to molecular response | 12 months therapy | To compare the time to molecular response (major or complete) |
| Secondary | Relationship between peak plasmatic level and efficacy | 12 months therapy | To analyse the relationship between peak plasmatic level (Cmax) and efficacy in the three arms |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34195988 | RESULT |
Source PubMed
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/NCT01916785
GET https://conductscience.org/api/trials/v1/NCT01916785/registered