Trial · NCT04590248
A Study of Adavosertib as Treatment for Uterine Serous Carcinoma
NCT04590248, Phase 2, Completed, AstraZeneca; results first posted 2023-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Adavosertib as Treatment for Uterine Serous Carcinoma. Trials, record NCT04590248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04590248
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Adavosertib as Treatment for Uterine Serous Carcinoma
- NCT number
- NCT04590248
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Uterine Serous Carcinoma
- Interventions
- Adavosertib
- First posted
- 2020-10-19
- Last updated
- 2023-08-14
- Results first posted
- 2023-08-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | up to 75 weeks | Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 for target lesions (TLs) and assessed by computed tomography (CT) or magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions; Partial response (PR), \>=30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. |
| Secondary | Duration of Response (DoR) | up to 75 weeks | The time from the date of first documented response until date of documented progression per RECIST v1.1 as assessed by BICR, or death in the absence of disease progression |
| Secondary | Depth of Response | Up to 75 weeks | Depth of response is defined as best percentage change from baseline in target lesion size, which is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction. A negative change denotes a reduction in target lesion size. |
| Secondary | Progression Free Survival (PFS) | Up to 75 weeks | The time from first dose until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraws from study drug or receives another anticancer therapy prior to progression. PFS was assessed per RECIST v1.1 using CT or MRI scans by BICR. |
| Secondary | Progression Free Survival Rate at 6 Months (PFS6) | Up to 6 months | The progression free survival rate was assessed at 6 months by Kaplan-Meier estimate per RECIST v1.1. |
| Secondary | Overall Survival (OS) | Up to 75 weeks | The time from date of first dose until the date of death due to any cause |
| Secondary | Disease Control Rate (DCR) | Up to 75 weeks | The percentage of participants who have a best overall response of confirmed response (CR) or partial response (PR) or who have stable disease for at least 5 weeks after start of treatment, based on BICR. |
| Secondary | Lowest Concentration (Ctrough) of Adavosertib | Cycle 1, Day 5 and Cycle 2, Day 5 (pre-dose) (each cycle is 21 days) | Lowest plasma concentration of adavosertib was evaluated as pharmacokinetic paramerter. |
| Secondary | Maximum Concentration (Cmax) of Adavosertib | Cycle 1, Day 5 and Cycle 2, Day 5 (2 hours post-dose) (each cycle is 21 days) | Maximum plasma concentration of adavosertib was evaluated as pharmacokinetic parameter. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) | From baseline to post-treatment follow-up (30 days after last dose), approximately up to 114 weeks | The number of participants with treatment emergent adverse events (AEs) were assessed as variable of safety and tolerability. The adverse events reported here were treatment emergent. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | up to 75 weeks | FAS, which included all participants who received at least one (non-zero) dose of study treatment. Here, overall number of participants analyzed signifies the participant with available data that were analyzed for the outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | up to 75 weeks | FAS, which included all participants who received at least one (non-zero) dose of study treatment and had a confirmed response. | Months | MEDIAN |
| SECONDARY | Depth of Response | Up to 75 weeks | FAS, which included all participants who received at least one (non-zero) dose of study treatment. Here, overall number of participants analyzed signifies the participant with available data that were analyzed for the outcome measure. | Percentage change | MEAN |
| SECONDARY | Progression Free Survival (PFS) | Up to 75 weeks | FAS, which included all participants who received at least one (non-zero) dose of study treatment. | Months | MEDIAN |
| SECONDARY | Progression Free Survival Rate at 6 Months (PFS6) | Up to 6 months | FAS, which included all participants who received at least one (non-zero) dose of study treatment. | Percentage | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 75 weeks | FAS, which included all participants who received at least one (non-zero) dose of study treatment. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Up to 75 weeks | FAS, which included all subjects who received at least one (non-zero) dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Lowest Concentration (Ctrough) of Adavosertib | Cycle 1, Day 5 and Cycle 2, Day 5 (pre-dose) (each cycle is 21 days) | The pharmacokinetic analysis set included all dosed participants who had at least one measurable plasma concentration collected post-dose which was obtained without any deviation or event thought to significantly affect the pharmacokinetic analysis. Here, overall number of participants analyzed signifies in each row the participant with available data, that was analyzed for specific time points. | nanomole (nM) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Concentration (Cmax) of Adavosertib | Cycle 1, Day 5 and Cycle 2, Day 5 (2 hours post-dose) (each cycle is 21 days) | The pharmacokinetic analysis set included all dosed participants who had at least one measurable plasma concentration collected post-dose which was obtained without any deviation or event thought to significantly affect the pharmacokinetic analysis. Here, overall number of participants analyzed in each row signifies the participant with available data, that was analyzed for specific time points. | nM | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) | From baseline to post-treatment follow-up (30 days after last dose), approximately up to 114 weeks | FAS, which included all participants who received at least one (non-zero) dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Adavosertib | 26 | 95% Confidence Interval 17.9 to 35.5 | Percentage of participants | |
| Duration of Response (DoR) | Adavosertib | 4.7 | Full Range 1.4 to 10.5 | Months | |
| Depth of Response | Adavosertib | -20.8 | Standard Deviation 31.60 | Percentage change | |
| Progression Free Survival (PFS) | Adavosertib | 2.8 | 95% Confidence Interval 2.60 to 3.94 | Months | |
| Progression Free Survival Rate at 6 Months (PFS6) | Adavosertib | 18.1 | 95% Confidence Interval 10.42 to 27.55 | Percentage | |
| Overall Survival (OS) | Adavosertib | 9.6 | 95% Confidence Interval 8.28 to NA | Months | |
| Disease Control Rate (DCR) | Adavosertib | 51.4 | 95% Confidence Interval 41.6 to 61.1 | Percentage of participants | |
| Lowest Concentration (Ctrough) of Adavosertib | Adavosertib | Cycle 1 Day 5 | 307.2 | Geometric Coefficient of Variation 105.6 | nanomole (nM) |
| Lowest Concentration (Ctrough) of Adavosertib | Adavosertib | Cycle 2 Day 5 | 328.7 | Geometric Coefficient of Variation 70.3 | nanomole (nM) |
| Maximum Concentration (Cmax) of Adavosertib | Adavosertib | Cycle 1 Day 5 | 1115.9 | Geometric Coefficient of Variation 82.1 | nM |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adavosertib | 109 | |
| Overall Study | COMPLETED | Adavosertib | 90 | |
| Overall Study | NOT COMPLETED | Adavosertib | 19 |
Source ClinicalTrials.gov
Adverse events109
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 | Urinary tract infection | Infections and infestations | Adavosertib | 16 | 109 | 19 |
| other | Anaemia | Blood and lymphatic system disorders | Adavosertib | 74 | 109 | 155 |
| other | Leukopenia | Blood and lymphatic system disorders | Adavosertib | 8 | 109 | 15 |
| other | Neutropenia | Blood and lymphatic system disorders | Adavosertib | 26 | 109 | 48 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Adavosertib | 27 | 109 | 40 |
| other | Decreased appetite | Metabolism and nutrition disorders | Adavosertib | 27 | 109 | 39 |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Adavosertib | 18 | 109 | 21 |
| other | Hypoalbuminaemia | Metabolism and nutrition disorders | Adavosertib | 10 | 109 | 18 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Adavosertib | 21 | 109 | 27 |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | Adavosertib | 17 | 109 | 27 |
1 to 10 of 109Source ClinicalTrials.gov
See all 109 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adavosertib | 47 | 109 |
| Total, other adverse events | Adavosertib | 109 | 109 |
| Total, serious adverse events | Adavosertib | 53 | 109 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT04590248
GET https://conductscience.org/api/trials/v1/NCT04590248/results?page=2