Trial · NCT02095132
Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors
NCT02095132, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-10-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors. Trials, record NCT02095132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02095132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors
- NCT number
- NCT02095132
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Central Nervous System Embryonal Tumor With Rhabdoid Features, Central Nervous System Embryonal Tumor, Not Otherwise Specified, Central Nervous System Ganglioneuroblastoma, Embryonal Tumor With Multilayered Rosettes, C19MC-Altered, Pineoblastoma, Primary Central Nervous System Neoplasm, Recurrent Childhood Central Nervous System Embryonal Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Rhabdomyosarcoma, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Rhabdomyosarcoma
- Interventions
- Adavosertib, Irinotecan Hydrochloride
- First posted
- 2014-03-24
- Last updated
- 2023-09-26
- Results first posted
- 2022-10-05
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) | Up to 21 days | MTD is defined as the maximum doses of adavosertib and irinotecan hydrochloride at which fewer than one-third of patients experience dose limiting toxicities when receiving this combination. |
| Primary | Number of Participants With Cycle 1 DLT | Up to 21 days | To define and describe the toxicities of AZD1755 (MK-1775) in combination with oral irinotecan administered on this schedule. |
| Primary | Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, AUC | Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2 | The PK parameters will be summarized by means and standard deviations |
| Primary | Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Cmax | Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2 | The PK parameters will be summarized by means and standard deviations |
| Primary | Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, HL-Lambda (Half Life) | Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2 | The PK parameters will be summarized by means and standard deviations |
| Primary | Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Tmax | Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2 | The PK parameters will be summarized by means and standard deviations |
| Secondary | Number and Percentage of Participants With Best Overall Response With Partial or Complete Response | Up to 1 year | Frequency (%) of response-evaluable patients with best overall response of partial or complete response as determined by revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). |
| Secondary | Mean Fold Change in Gamma H2AX in Peripheral Blood Mono Nuclear Cells | Up to 1 day | Mean (SD) of the increase in gamma H2AX at 4 hours versus baseline among patients in Part A stratified by dose level. |
| Secondary | Number and Percentage of Part B Neuroblastoma Participants With MYCN Amplification | Assessed at Baseline | Frequency (%) of Part B Neuroblastoma participants with MYCN amplification. |
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) | Up to 21 days | All Part A patients contributed to determining MTD. Only Toxicity evaluable patients were accounted. | mg/m^2 | NUMBER |
| PRIMARY | Number of Participants With Cycle 1 DLT | Up to 21 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, AUC | Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2 | Summary statistics for PK parameter for patients in Part A. Per study protocol, PK measures were not required for Parts B, C, or D, therefore, data were not and will not be collected. | hr*nmol/L | MEAN |
| PRIMARY | Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Cmax | Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2 | Summary statistics for PK parameter for patients in Part A. Per study protocol, PK measures were not required for Parts B, C, or D, therefore, data were not and will not be collected. | nmol/L | MEAN |
| PRIMARY | Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, HL-Lambda (Half Life) | Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2 | Summary statistics for PK parameter for patients in Part A. Per study protocol, PK measures were not required for Parts B, C, or D, therefore, data were not and will not be collected. | hours | MEAN |
| PRIMARY | Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Tmax | Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2 | Summary statistics for PK parameter for patients in Part A. Per study protocol, PK measures were not required for Parts B, C, or D, therefore, data were not and will not be collected. | hours | MEAN |
| SECONDARY | Number and Percentage of Participants With Best Overall Response With Partial or Complete Response | Up to 1 year | Patients with complete response or partial response among response-evaluable patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Fold Change in Gamma H2AX in Peripheral Blood Mono Nuclear Cells | Up to 1 day | Part A patients with data available. Per study protocol, pharmacodynamics were not required for Parts B, C, or D, therefore, data were not collected and will not be collected. | Fold change | MEAN |
| SECONDARY | Number and Percentage of Part B Neuroblastoma Participants With MYCN Amplification | Assessed at Baseline | Only Part B eligible patients. Per study protocol, data for Parts A, C, and D were not and will not ever be collected. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group50
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) | Part A | Irinotecan (IRIN) | 90 | mg/m^2 | |
| Maximum Tolerated Dose (MTD) | Part A | AZD1775 (MK-1775) | 85 | mg/m^2 | |
| Number of Participants With Cycle 1 DLT | Part A, Dose Level 1 | 0 | Participants | ||
| Number of Participants With Cycle 1 DLT | Part A, Dose Level 2 | 0 | Participants | ||
| Number of Participants With Cycle 1 DLT | Part A, Dose Level 3 | 0 | Participants | ||
| Number of Participants With Cycle 1 DLT | Part A, Dose Level 4 | 0 | Participants | ||
| Number of Participants With Cycle 1 DLT | Part A, Dose Level 5 | 2 | Participants | ||
| Number of Participants With Cycle 1 DLT | Part A, PK Expansion | 0 | Participants | ||
| Number of Participants With Cycle 1 DLT | Part B, Neuroblastoma | 1 | Participants | ||
| Number of Participants With Cycle 1 DLT | Part C, Medulloblastoma/CNS PNET | 0 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A, Dose Level 1 | 4 | |
| Overall Study | STARTED | Part A, Dose Level 2 | 5 | |
| Overall Study | STARTED | Part A, Dose Level 3 | 4 | |
| Overall Study | STARTED | Part A, Dose Level 4 | 10 | |
| Overall Study | STARTED | Part A, Dose Level 5 | 8 | |
| Overall Study | STARTED | Part A, PK Expansion | 6 | |
| Overall Study | STARTED | Part B, Neuroblastoma | 19 | |
| Overall Study | STARTED | Part C, Medulloblastoma/CNS PNET | 10 | |
| Overall Study | STARTED | Part D, Rhabdomyosarcoma | 10 | |
| Overall Study | COMPLETED | Part A, Dose Level 1 | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events3,843
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 | Part A, Dose Level 1 | 0 | 4 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A, Dose Level 2 | 0 | 5 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A, Dose Level 3 | 0 | 4 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A, Dose Level 4 | 1 | 10 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A, Dose Level 5 | 2 | 8 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A, PK Expansion | 1 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part B, Neuroblastoma | 0 | 19 | |
| other | Abdominal distension | Gastrointestinal disorders | Part C, Medulloblastoma/CNS PNET | 0 | 10 | |
| other | Abdominal distension | Gastrointestinal disorders | Part D, Rhabdomyosarcoma | 0 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A, Dose Level 1 | 2 | 4 |
1 to 10 of 3,843Source ClinicalTrials.gov
See all 3,843 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A, Dose Level 1 | 1 | 4 |
| Total, all-cause mortality | Part A, Dose Level 2 | 0 | 5 |
| Total, all-cause mortality | Part A, Dose Level 3 | 0 | 4 |
| Total, all-cause mortality | Part A, Dose Level 4 | 0 | 10 |
| Total, all-cause mortality | Part A, Dose Level 5 | 0 | 8 |
| Total, all-cause mortality | Part A, PK Expansion | 0 | 6 |
| Total, all-cause mortality | Part B, Neuroblastoma | 1 | 19 |
| Total, all-cause mortality | Part C, Medulloblastoma/CNS PNET | 1 | 10 |
| Total, all-cause mortality | Part D, Rhabdomyosarcoma | 1 | 10 |
| Total, other adverse events | Part A, Dose Level 1 | 4 | 4 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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/NCT02095132
GET https://conductscience.org/api/trials/v1/NCT02095132/results?page=2