Trial · NCT01922076
Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
NCT01922076, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2024-01-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas. Trials, record NCT01922076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01922076
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
- NCT number
- NCT01922076
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 46 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Glioblastoma, Gliosarcoma
- Interventions
- Adavosertib, Laboratory Biomarker Analysis, Pharmacological Study, Radiation Therapy
- First posted
- 2013-08-14
- Last updated
- 2024-01-31
- Results first posted
- 2024-01-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose of Adavosertib | Up to 42 days | MTD will be defined as the maximum dose at which fewer than one-third of patients experience a dose-limiting toxicity graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
| Primary | Number of Dose Limiting Toxicity With Adavosertib | Up to 42 days | Number of patients with dose limiting toxicity stratified by dose level and the toxicity will be graded using the NCI CTCAE version 4.0. |
| Primary | Area Under the Time Concentration Curve of Adavosertib | up to 24 hours | Median (min, max) of the area under the concentration time curve adavosertib assessed at 1, 2, 4, 6, 8, and 24 hours post dose on day 1 stratified by dose level and study part. |
| Secondary | Number of Patients With Response to Adavosertib | Up to 4 years | Number of participants with response (CR/PR) by maximal 2-dimensional measures with CR: disappearance of all abnormal signal within the brainstem; PR: at least 50% decrease in the sum o the products of the two perpendicular diameters of the target lesion. |
| Secondary | Progression-free Survival (PFS) of Adavosertib | Up to 4 years | Median (95% CI) time to progression or death stratified by dose level and study part. PFS was defined as time from start date of the first treatment to the date of disease progression or death due to any causes which ever occurred first. |
| Secondary | Overall Survival (OS) of Adavosertib | Up to 4 years | Median (95% CI) time to progression or death stratified by dose level and study part. |
| Secondary | Change in p-CDC2 of Adavosertib | Baseline to day 8 | Median (min, max) change in expression of p-CDC2 in peripheral blood mononuclear cells (PBMCs) before and after administration by dose level and study part. |
| Secondary | Change in Expression of p-HH3 of Adavosertib | Baseline to day 8 | Median (min, max) change in expression of p-HH3 in peripheral blood mononuclear cells (PBMCs) before and after administration by dose level and study part |
| Secondary | Change in Expression of ɤ(Gamma)-H2AX of Adavosertib | Baseline to day 8 | Median (min, max) relative change in expression of gamma-H2AX of adavosertib by dose level and study part. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose of Adavosertib | Up to 42 days | All eligible patients | mg/m^2 | NUMBER |
| PRIMARY | Number of Dose Limiting Toxicity With Adavosertib | Up to 42 days | All Toxicity evaluable patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Area Under the Time Concentration Curve of Adavosertib | up to 24 hours | All eligible patients | hr*ng/mL | MEDIAN |
| SECONDARY | Number of Patients With Response to Adavosertib | Up to 4 years | All response evaluable patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) of Adavosertib | Up to 4 years | All response evaluable patients | Days | MEDIAN |
| SECONDARY | Overall Survival (OS) of Adavosertib | Up to 4 years | All response evaluable patients | Days | MEDIAN |
| SECONDARY | Change in p-CDC2 of Adavosertib | Baseline to day 8 | Data were not and will never be collected. | ||
| SECONDARY | Change in Expression of p-HH3 of Adavosertib | Baseline to day 8 | Data were not and will never be collected. | ||
| SECONDARY | Change in Expression of ɤ(Gamma)-H2AX of Adavosertib | Baseline to day 8 | ratio | MEDIAN |
Source ClinicalTrials.gov
Results by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose of Adavosertib | Treatment (Adavosertib) | 200 | mg/m^2 | ||
| Number of Dose Limiting Toxicity With Adavosertib | Dose Level 1: 50 mg/m^2 | 0 | Participants | ||
| Number of Dose Limiting Toxicity With Adavosertib | Dose Level 2: 50 mg/m^2 | 0 | Participants | ||
| Number of Dose Limiting Toxicity With Adavosertib | Dose Level 3: 50 mg/m^2 | 0 | Participants | ||
| Number of Dose Limiting Toxicity With Adavosertib | Dose Level 4: 95 mg/m^2 | 1 | Participants | ||
| Number of Dose Limiting Toxicity With Adavosertib | Dose Level 5: 130 mg/m^2 | 0 | Participants | ||
| Number of Dose Limiting Toxicity With Adavosertib | Dose Level 6: 160 mg/m^2 | 0 | Participants | ||
| Number of Dose Limiting Toxicity With Adavosertib | Dose Level 7: 200 mg/m^2 | 1 | Participants | ||
| Area Under the Time Concentration Curve of Adavosertib | Dose Level 1: 50 mg/m^2 | 1122.2 | Full Range 918.1 to 1839.4 | hr*ng/mL | |
| Area Under the Time Concentration Curve of Adavosertib | Dose Level 2: 50 mg/m^2 | 1233.3 | Full Range 540.5 to 1511.7 | hr*ng/mL |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1: 50 mg/m^2 | 6 | |
| Overall Study | STARTED | Dose Level 2: 50 mg/m^2 | 6 | |
| Overall Study | STARTED | Dose Level 3: 50 mg/m^2 | 7 | |
| Overall Study | STARTED | Dose Level 4: 95 mg/m^2 | 7 | |
| Overall Study | STARTED | Dose Level 5: 130 mg/m^2 | 7 | |
| Overall Study | STARTED | Dose Level 6: 160 mg/m^2 | 6 | |
| Overall Study | STARTED | Dose Level 7: 200 mg/m^2 | 7 | |
| Overall Study | COMPLETED | Dose Level 1: 50 mg/m^2 | 6 | |
| Overall Study | COMPLETED | Dose Level 2: 50 mg/m^2 | 6 | |
| Overall Study | COMPLETED | Dose Level 3: 50 mg/m^2 | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,876
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 | Abdominal distension | Gastrointestinal disorders | Dose Level 1: 50 mg/m^2 | 1 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Level 2: 50 mg/m^2 | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Level 3: 50 mg/m^2 | 2 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Level 4: 95 mg/m^2 | 2 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Level 5: 130 mg/m^2 | 0 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Level 6: 160 mg/m^2 | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Dose Level 7: 200 mg/m^2 | 0 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 1: 50 mg/m^2 | 3 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 2: 50 mg/m^2 | 2 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 3: 50 mg/m^2 | 2 | 7 |
1 to 10 of 1,876Source ClinicalTrials.gov
See all 1,876 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1: 50 mg/m^2 | 4 | 6 |
| Total, all-cause mortality | Dose Level 2: 50 mg/m^2 | 4 | 6 |
| Total, all-cause mortality | Dose Level 3: 50 mg/m^2 | 4 | 7 |
| Total, all-cause mortality | Dose Level 4: 95 mg/m^2 | 4 | 7 |
| Total, all-cause mortality | Dose Level 5: 130 mg/m^2 | 6 | 7 |
| Total, all-cause mortality | Dose Level 6: 160 mg/m^2 | 4 | 6 |
| Total, all-cause mortality | Dose Level 7: 200 mg/m^2 | 4 | 7 |
| Total, other adverse events | Dose Level 1: 50 mg/m^2 | 6 | 6 |
| Total, other adverse events | Dose Level 2: 50 mg/m^2 | 6 | 6 |
| Total, other adverse events | Dose Level 3: 50 mg/m^2 | 7 | 7 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| UM1CA097452 | Pediatric Phase 1/Pilot Consortium | WEIGEL, BRENDA J. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2009 to 2018 |
Source 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/NCT01922076
GET https://conductscience.org/api/trials/v1/NCT01922076/results?page=2