Trial · NCT02975882
Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
NCT02975882, Phase 1, Completed, Children's Oncology Group; results first posted 2023-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors. Trials, record NCT02975882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02975882
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
- NCT number
- NCT02975882
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 33 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Childhood Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Primary Central Nervous System Neoplasm, Refractory Malignant Solid Neoplasm, Refractory Primary Central Nervous System Neoplasm
- Interventions
- Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Sirolimus Albumin-bound Nanoparticles, Temozolomide
- First posted
- 2016-11-29
- Last updated
- 2025-01-14
- Results first posted
- 2023-03-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Cycle 1 and 2 Dose Limiting Toxicities Attributable to Nanoparticle Albumin-bound Rapamycin | Up to 42 days | Number of patients with cycle 1 and 2 dose limiting toxicities possibly, probably, or definitely attributable with nanoparticle albumin-bound rapamycin stratified by dose level. |
| Primary | Number of Patients With Adverse Events | Up to 24 months | The number of patients with adverse events that are at least possibly attributable to nanoparticle albumin-bound rapamycin stratified by dose level. |
| Primary | Area Under the Serum of Nanoparticle Albumin-bound Rapamycin Concentration Curve | Days 1, 2, 3, 4, and 8 | Median with minimum and maximum values of the area under the drug concentration over time curve stratified by dose level. |
| Secondary | Number of Patients With Antitumor Activity of Nanoparticle Albumin-bound Rapamycin | Up to 24 months | The number of response-evaluable patients with best overall response of complete response (CR), disappearance of all target lesions; or partial response (PR), \>=50% decrease in the sum of the products of the two perpendicular diameters of all target lesions (up to 5), while on study therapy stratified by dose level; Overall response (OR)=CR+PR. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Cycle 1 and 2 Dose Limiting Toxicities Attributable to Nanoparticle Albumin-bound Rapamycin | Up to 42 days | All DLT evaluable Patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With Adverse Events | Up to 24 months | All Eligible Patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Area Under the Serum of Nanoparticle Albumin-bound Rapamycin Concentration Curve | Days 1, 2, 3, 4, and 8 | All Eligible Patients | hr*ng/mL | MEAN |
| SECONDARY | Number of Patients With Antitumor Activity of Nanoparticle Albumin-bound Rapamycin | Up to 24 months | All Eligible Patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Cycle 1 and 2 Dose Limiting Toxicities Attributable to Nanoparticle Albumin-bound Rapamycin | Stratum Cohort With Dose Level 1 | 1 | Participants | ||
| Number of Patients With Cycle 1 and 2 Dose Limiting Toxicities Attributable to Nanoparticle Albumin-bound Rapamycin | Stratum Cohort With Dose Level -1 | 2 | Participants | ||
| Number of Patients With Cycle 1 and 2 Dose Limiting Toxicities Attributable to Nanoparticle Albumin-bound Rapamycin | Stratum Cohort With Dose Level -2 | 1 | Participants | ||
| Number of Patients With Cycle 1 and 2 Dose Limiting Toxicities Attributable to Nanoparticle Albumin-bound Rapamycin | PK Cohort With Dose Level -2 | 1 | Participants | ||
| Number of Patients With Adverse Events | Stratum Cohort With Dose Level 1 | 4 | Participants | ||
| Number of Patients With Adverse Events | Stratum Cohort With Dose Level -1 | 12 | Participants | ||
| Number of Patients With Adverse Events | Stratum Cohort With Dose Level -2 | 8 | Participants | ||
| Number of Patients With Adverse Events | PK Cohort With Dose Level -2 | 5 | Participants | ||
| Area Under the Serum of Nanoparticle Albumin-bound Rapamycin Concentration Curve | Stratum Cohort With Dose Level 1 | 13654 | Full Range 8610.0 to 19617.0 | hr*ng/mL | |
| Area Under the Serum of Nanoparticle Albumin-bound Rapamycin Concentration Curve | Stratum Cohort With Dose Level -1 | 9532 | Full Range 5352.0 to 18625.0 | hr*ng/mL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum Cohort With Dose Level 1 | 5 | |
| Overall Study | STARTED | Stratum Cohort With Dose Level -1 | 13 | |
| Overall Study | STARTED | Stratum Cohort With Dose Level -2 | 9 | |
| Overall Study | STARTED | PK Cohort With Dose Level -2 | 6 | |
| Overall Study | COMPLETED | Stratum Cohort With Dose Level 1 | 1 | |
| Overall Study | COMPLETED | Stratum Cohort With Dose Level -1 | 0 | |
| Overall Study | COMPLETED | Stratum Cohort With Dose Level -2 | 0 | |
| Overall Study | COMPLETED | PK Cohort With Dose Level -2 | 0 | |
| Overall Study | NOT COMPLETED | Stratum Cohort With Dose Level 1 | 4 | |
| Overall Study | NOT COMPLETED | Stratum Cohort With Dose Level -1 | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,088
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 | Stratum Cohort With Dose Level 1 | 1 | 5 | |
| other | Abdominal distension | Gastrointestinal disorders | Stratum Cohort With Dose Level -1 | 2 | 12 | |
| other | Abdominal distension | Gastrointestinal disorders | Stratum Cohort With Dose Level -2 | 1 | 9 | |
| other | Abdominal distension | Gastrointestinal disorders | PK Cohort With Dose Level -2 | 1 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Stratum Cohort With Dose Level 1 | 3 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Stratum Cohort With Dose Level -1 | 4 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Stratum Cohort With Dose Level -2 | 3 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | PK Cohort With Dose Level -2 | 2 | 6 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Stratum Cohort With Dose Level 1 | 0 | 5 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Stratum Cohort With Dose Level -1 | 1 | 12 |
1 to 10 of 1,088Source ClinicalTrials.gov
See all 1,088 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum Cohort With Dose Level 1 | 0 | 5 |
| Total, all-cause mortality | Stratum Cohort With Dose Level -1 | 2 | 12 |
| Total, all-cause mortality | Stratum Cohort With Dose Level -2 | 1 | 9 |
| Total, all-cause mortality | PK Cohort With Dose Level -2 | 0 | 6 |
| Total, other adverse events | Stratum Cohort With Dose Level 1 | 5 | 5 |
| Total, other adverse events | Stratum Cohort With Dose Level -1 | 12 | 12 |
| Total, other adverse events | Stratum Cohort With Dose Level -2 | 9 | 9 |
| Total, other adverse events | PK Cohort With Dose Level -2 | 6 | 6 |
| Total, serious adverse events | Stratum Cohort With Dose Level 1 | 4 | 5 |
| Total, serious adverse events | Stratum Cohort With Dose Level -1 | 12 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39487711 | DERIVED |
Source PubMed
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/NCT02975882
GET https://conductscience.org/api/trials/v1/NCT02975882/events?page=2