Trial · NCT00632749
BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment
NCT00632749, Phase 2, Completed, Boehringer Ingelheim; results first posted 2015-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment. Trials, record NCT00632749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00632749
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment
- NCT number
- NCT00632749
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 68 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- BI 811283 (d 1 and 15), Cytarabine, BI 811283 (d1), Cytarabine
- First posted
- 2008-03-11
- Last updated
- 2015-09-14
- Other registries' IDs
- eudract:2007-005684-10
- Results first posted
- 2015-05-25
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine. | up to 28 days of treatment | The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only. It was determined using a standard "3 + 3 design with de-escalation". |
| Secondary | Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | Data collected up to cut-off date 20Oct2011, Up to 1239 days | Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria: The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment. * Complete remission (CR): morphologically leukaemia free state (i.e. bone marrow with \< 5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥ 1,000/μL and platelets \> 100,000/μL. * Complete remission with incomplete blood count recovery ("incomplete" CR, CRi).All of the above criteria for CR had to be met, except that neutrophils \< 1,000/μL or platelets \< 100,000/μL in the blood. |
| Secondary | Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0) | Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days | The severity and timing of AEs indicates how well the treatment regimen was tolerated. Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme. |
| Secondary | Incidence of Dose Limiting Toxicity (DLT) | up to 28 days of treatment | Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD) |
| Secondary | Partial Remission | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment. Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or \< 5% blasts in the presence of Auer rods or abnormal morphology. |
| Secondary | Event Free Survival (EFS) | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first. |
| Secondary | Relapse Free Survival | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first. Number of patients having relapse free survival are presented. |
| Secondary | Remission Duration | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause. |
| Secondary | Overall Survival (OS) | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause. |
| Secondary | Cmax (Maximum Measured Concentration of BI 811283 in Plasma) | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 | Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine. | up to 28 days of treatment | Treated set (TS): All patients who received at least one single dose of trial medication (BI 811283 or cytarabine) were considered. | mg | NUMBER |
| SECONDARY | Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | Data collected up to cut-off date 20Oct2011, Up to 1239 days | Treated set | participants | NUMBER |
| SECONDARY | Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0) | Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days | Treated set | participants | NUMBER |
| SECONDARY | Incidence of Dose Limiting Toxicity (DLT) | up to 28 days of treatment | Treated set | participants | NUMBER |
| SECONDARY | Partial Remission | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | Treated set | participants | NUMBER |
| SECONDARY | Event Free Survival (EFS) | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | Treated set | days | MEAN |
| SECONDARY | Relapse Free Survival | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | Treated set (Only patients with observed cases (OC) values were analysed) | participants | NUMBER |
| SECONDARY | Remission Duration | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | Treated set (Only patients with observed cases (OC) values were analysed) | days | MEAN |
| SECONDARY | Overall Survival (OS) | Data collected up to cut-off date 20 Oct 2011, Up to 1239 days | Treated set | days | MEAN |
| SECONDARY | Cmax (Maximum Measured Concentration of BI 811283 in Plasma) | -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283 | Treated Set (Only patients with observed cases (OC) values were analysed) | nmol/L | GEOMETRIC_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group305
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine. | Treatment Schedule A | 100 | mg | ||
| The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine. | Treatment Schedule B | NA | mg | ||
| Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | CR | 0 | participants | |
| Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | 15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | CR | 0 | participants | |
| Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | CR | 0 | participants | |
| Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | CR | 1 | participants | |
| Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | CR | 0 | participants | |
| Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | CR | 1 | participants | |
| Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | CR | 1 | participants | |
| Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi]) | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | CR | 0 | participants |
1 to 10 of 305Source ClinicalTrials.gov
See all 305 results by groupParticipant flow70
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 4 | |
| Overall Study | STARTED | 15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 5 | |
| Overall Study | STARTED | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 3 | |
| Overall Study | STARTED | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 4 | |
| Overall Study | STARTED | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 7 | |
| Overall Study | STARTED | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 8 | |
| Overall Study | STARTED | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 5 | |
| Overall Study | STARTED | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 4 | |
| Overall Study | STARTED | 80 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B | 5 | |
| Overall Study | STARTED | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 3 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 participant flowAdverse events6,202
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 | Anaemia | Blood and lymphatic system disorders | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | 15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 5 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | 5 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 1 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | 3 | 3 |
1 to 10 of 6,202Source ClinicalTrials.gov
See all 6,202 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | ||
| Total, all-cause mortality | 15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | ||
| Total, all-cause mortality | 30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | ||
| Total, all-cause mortality | 60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | ||
| Total, all-cause mortality | 100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | ||
| Total, all-cause mortality | 120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A | ||
| Total, all-cause mortality | 5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | ||
| Total, all-cause mortality | 40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | ||
| Total, all-cause mortality | 80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B | ||
| Total, all-cause mortality | 160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30450591 | 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/NCT00632749
GET https://conductscience.org/api/trials/v1/NCT00632749/registered?page=2