Trial · NCT00486265
Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)
NCT00486265, Phase 1, Terminated, AstraZeneca; results first posted 2010-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML). Trials, record NCT00486265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00486265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)
- NCT number
- NCT00486265
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 47 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Acute Myelogenous Leukemia
- Interventions
- AZD4877
- First posted
- 2007-06-14
- Last updated
- 2010-12-21
- Results first posted
- 2010-08-17
- Limitations and caveats
On 16 June 2009, the study was terminated for a lack of efficacy. None of the 8 patients had experienced CR or CRi. The secondary efficacy outcome measures were not evaluated due to early termination and small number of participants.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs) | Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period. | To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs) |
| Primary | To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR) | Response is evaluated after a maximum of 2 courses of induction therapy. | Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure. |
| Primary | To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ] | PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8. | Maximum plasma concentration, Cmax |
| Secondary | To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR) | Response is evaluated after a maximum of 2 courses of induction therapy. | Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure. |
| Secondary | To Evaluate the Safety and Tolerability of AZD4877 on a Daily x 3 Schedule by Assessment of Adverse Events, Non-hematologic Labs and Vital Signs | Patients were followed for safety from the date of first dose of AZD4877 up to 30-days after the last administration of AZD4877, where possible. |
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 | To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs) | Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period. | Participants | NUMBER | |
| PRIMARY | To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR) | Response is evaluated after a maximum of 2 courses of induction therapy. | 8 of 9 patients in Part B were evaluable for response following a maximum of 2 courses of induction therapy. | Participants | NUMBER |
| PRIMARY | To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ] | PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8. | ng/mL | GEOMETRIC_MEAN | |
| SECONDARY | To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR) | Response is evaluated after a maximum of 2 courses of induction therapy. | Participants | NUMBER | |
| SECONDARY | To Evaluate the Safety and Tolerability of AZD4877 on a Daily x 3 Schedule by Assessment of Adverse Events, Non-hematologic Labs and Vital Signs | Patients were followed for safety from the date of first dose of AZD4877 up to 30-days after the last administration of AZD4877, where possible. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR) | AZD4877 | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD4877 | 9 | |
| Overall Study | COMPLETED | AZD4877 | 0 | |
| Overall Study | NOT COMPLETED | AZD4877 | 9 |
Source ClinicalTrials.gov
Adverse events69
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 | AZD4877 | 1 | 9 | |
| other | Leukopenia | Blood and lymphatic system disorders | AZD4877 | 1 | 9 | |
| other | Neutropenia | Blood and lymphatic system disorders | AZD4877 | 1 | 9 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | AZD4877 | 1 | 9 | |
| other | Sinus Tachycardia | Cardiac disorders | AZD4877 | 1 | 9 | |
| other | Hypophosphatasia | Congenital, familial and genetic disorders | AZD4877 | 1 | 9 | |
| other | Ear Pain | Ear and labyrinth disorders | AZD4877 | 1 | 9 | |
| other | Dry Eye | Eye disorders | AZD4877 | 1 | 9 | |
| other | Constipation | Gastrointestinal disorders | AZD4877 | 3 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | AZD4877 | 3 | 9 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD4877 | ||
| Total, other adverse events | AZD4877 | 9 | 9 |
| Total, serious adverse events | AZD4877 | 3 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21494838 | 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/NCT00486265
GET https://conductscience.org/api/trials/v1/NCT00486265/events?page=2