Trial · NCT01756118
A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia
NCT01756118, Phase 1, Completed, Goethe University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia. Trials, record NCT01756118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01756118
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia
- NCT number
- NCT01756118
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Goethe University
- Conditions
- Acute Lymphoblastic Leukemia, Leukemia, Myelocytic, Acute, Chronic Myelogenous Leukemia With Crisis of Blast Cells
- Interventions
- BEZ235
- First posted
- 2012-12-24
- Last updated
- 2023-02-16
- Other registries' IDs
- eudract:2011-005050-61
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 dose (RP2D) of BEZ235 in acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and chronic myeloid leukemia in blastic phase (CML-BP) | 6 months after inclusion of first patient | |
| Primary | Incidence of dose-limiting toxicity (DLT) | 6 months after inclusion of first patient | |
| Secondary | Adverse events as graded by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4. | 1.5 years | |
| Secondary | Investigator-reported best overall response (BOR) as determined from the response categories during treatment period. | 1.5 years | |
| Secondary | Time to progression | 1.5 years | |
| Secondary | Remission duration | 1.5 years | |
| Secondary | Biomarker evaluation | 1.5 years | |
| Secondary | BEZ235 and metabolite levels in plasma | 1.5 years | |
| Secondary | Clinical laboratory tests as graded by NCI CTCAE v4. | 1.5 years |
Source ClinicalTrials.gov
Outcomes0
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 |
|---|---|
| 32993794 | DERIVED |
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/NCT01756118
GET https://conductscience.org/api/trials/v1/NCT01756118/registered