Trial · NCT02381548
Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia
NCT02381548, Phase 1, Terminated, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia. Trials, record NCT02381548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02381548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia
- NCT number
- NCT02381548
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Myelodysplastic Syndrome, Recurrent Adult Acute Myeloid Leukemia, Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive, Refractory Acute Myeloid Leukemia, Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive, Secondary Acute Myeloid Leukemia
- Interventions
- Adavosertib, Belinostat, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2015-03-06
- Last updated
- 2026-01-30
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) for the combination of WEE1 inhibitor AZD1775 and belinostat, defined as the dose in which =< 1 out of 6 patients at highest dose level below the maximally administered dose experience dose-limiting toxicities (DLTs) | 21 days | Patients' treatment dosing level, dose modification, DLTs, and evaluability for DLTs will be listed and summarized by basic descriptive statistics (such as frequency and proportion). DLTs will be assessed according to the National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. |
| Secondary | Incidence of toxicity graded according to the National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Up to 30 days after completion of study treatment | Adverse events (AEs) and serious AEs, dosing levels, treatment received, best clinical response, and demographics will be listed. Basic descriptive statistics will be used to summarize toxicities related to the study drugs by grade, and all toxicities, whether related or unrelated to the study drugs, and duration of response or stable disease to the combination therapy. |
| Secondary | Response rate (complete remission [CR] + CR with incomplete blood count recovery [CRi] + cytogenetic CR [CRc] + molecular CR [CRm]) according to International Working Group and European Leukemia Net criteria | Up to 2 years | The clinical best response rates will be calculated for each dose level, along with their corresponding 95% confidence intervals. |
| Secondary | Duration of response (in patients with (complete remission [CR] + CR with incomplete blood count recovery [CRi] + cytogenetic CR [CRc] + molecular CR [CRm]) | From documentation of tumor response to disease progression or death, whichever occurs first, assessed up to 2 years | Duration of response will be summarized by the first, second, and third quantiles and illustrated by a Kaplan-Meier plot. |
| Secondary | Time to response | From registration to the time of documentation of tumor response, assessed up to 2 years | Time to response will be summarized by the first, second, and third quantiles and illustrated by a Kaplan-Meier plot. |
| Secondary | p53 and FLT3 mutation status | Up to 24 hours after first dose of study treatment | A Chi-square test and a Fisher exact test will be used to determine if there is a significant association between clinical responses and p53/FLT3 mutational status. An ordinal regression (where best clinical responses are considered as an ordinal outcome variable) and a logistic regression (where best responses are dichotomized as yes or no responses) will be used to test the association between responses and p53/FLT3 mutational status, with adjustment of potential factors (e.g., dose level, age, sex). |
| Secondary | Pharmacokinetic (PK) parameters (area under the curve [AUC], volume of distribution [Vd], peak concentration [Cmax], time to peak concentration [Tmax], and half-life [t1/2]) of belinostat | Day 1, course 1: pre-treatment, 5 minutes prior to the end of the belinostat infusion, 15 minutes (min), 30 min, 1 hour (hr), 2 hr, 4 hr, 6 hr, 8 hr, and 24 hr after the end of the belinostat infusion | Will be calculated using standard non-compartmental methods and summarized as geometric mean and geometric coefficient of variation. Cmax and the times needed to reach these concentrations (tmax) will be assessed by inspection of the concentration versus time plots. The AUC will be calculated from time zero to infinity. Vd and t1/2 will also be calculated. To discover any potential PK interactions between the 2 agents, each PK parameter will be compared with each referenced PK parameter for those who receive single-agent at the same amount dose by a one-sample t-test. |
| Secondary | PK parameters (area under the curve [AUC], volume of distribution [Vd], peak concentration [Cmax], time to peak concentration [Tmax], and half-life [t1/2]) of WEE1 inhibitor AZD1775 | Day 1, course 1: pre-treatment, and 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, and 24 hr after WEE1 inhibitor AZD1775 administration | Will be calculated respectively using standard non-compartmental methods and summarized as geometric mean and geometric coefficient of variation. Cmax and the times needed to reach these concentrations (tmax) will be assessed by inspection of the concentration versus time plots. The AUC will be calculated from time zero to infinity. Vd and t1/2 will also be calculated. To discover any potential PK interactions between the 2 agents, each PK parameter will be compared with each referenced PK parameter for those who receive single-agent at the same amount dose by a one-sample t-test. |
| Secondary | Changes in candidate biomarker levels (including p-Wee1, p-cdc2 and gamma-H2A.X) in bone marrow and/or blood samples | Baseline to 24 hours after first dose of study treatment | Various paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and in blood samples. Various simple regression models will be used to check if there is an effect of potential factors (e.g., dose level, age, sex) on the change. The distribution of the change will be checked and if the data is highly skewed, then an appropriate data transformation will be conducted to satisfy the assumption of normality. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UM1CA186644 | North American Star Consortium | BEDARD, PHILIPPE; COURTNEY, KEVIN D; GRANT, STEVEN; LANCET, JEFFREY; MAHALINGAM, DEVALINGAM; SIU, LILLIAN L | UNIVERSITY HEALTH NETWORK | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| UM1CA186716 | Wisconsin and New Jersey Alliance in Precision Experimental Therapeutics | JABBOUR, SALMA; LIU, GLENN | RBHS -CANCER INSTITUTE OF NEW JERSEY | NATIONAL CANCER INSTITUTE | 2014 to 2019 | NIH RePORTER |
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/NCT02381548
GET https://conductscience.org/api/trials/v1/NCT02381548/registered