Trial · NCT01606878
Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
NCT01606878, Phase 1, Completed, Children's Oncology Group; results first posted 2024-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma. Trials, record NCT01606878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01606878
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
- NCT number
- NCT01606878
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 46 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Childhood Solid Neoplasm, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Neuroblastoma
- Interventions
Crizotinib, Cyclophosphamide, Dexrazoxane Hydrochloride, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Questionnaire Administration, Topotecan Hydrochloride, Vincristine Sulfate
- First posted
- 2012-05-28
- Last updated
- 2024-01-05
- Results first posted
- 2024-01-05
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) of Crizotinib | Up to 21 days | The MTD of crizotinib administered with combination chemotherapy based on the incidence of dose-limiting toxicity (DLT) at which fewer than one-third of patients experience DLT, as assessed by NCI CTCAE version 4.0. |
| Primary | Number of Patients With Dose Limiting Toxicity (DLT) | Up to 21 days | Number of patients of all DLT reported as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. stratified by dose level and study part. |
| Primary | Area Under the Concentration | Up to 21 days | Median (min, max) of the area under the concentration time curve for crizotinib assessed in course 1 at 1, 2, 4, 6-8 hours, and 15-21 days post-administration stratified by dose level and study part. |
| Secondary | Response Rate | Up to 2 years | Number of patients of response-evaluable participants with response (CR/PR) assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 including CR: disappearance of all target and non-target lesions; PR: at least 30% decrease in the sum of the diameters of target lesions |
| Secondary | ALK Status and Response to Crizotinib | up to 2 years | Number of patients who respond (CR/PR) to crizotinib in combination with either topotecan and cyclophosphamide or vincristine and doxorubicin/dexraroxane stratified by ALK positive or negative status |
| Secondary | MRD Status and Response to Crizotinib | Up to 2 years | Frequency (%) of patients who respond (CR/PR) to crizotinib in combination with either topotecan and cyclophosphamide or vincristine and doxorubicin/dexraroxane stratified by MRD status |
| Secondary | ALK Expression for Crizotinib | Up to 7 days | Median (p25, p75) ALK expression stratified by dose level and study part |
| Secondary | Acceptability of Crizotinib Capsule Formulation Palatability | Up to 1 week | Number of patients who at least accept palatability of capsule formulation in the first week |
| Secondary | Acceptability of Crizotinib Microsphere Formulation Palatability | Up to 1 week | Number of patients who at least accept palatability of microsphere formation in the first week |
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) of Crizotinib | Up to 21 days | Parts A, B and D MTD/RP2D were not assessed. As of Amendment #3, due to the possibility that many of the non-hematologic DLTs observed to date on the study are related to the palatability of the OS rather than due to true toxicity of the investigational agent, Parts A and B were closed and Part C was then opened to determine the MTD/ RP2D. As of Amendment #4, a new microsphere formulation was added for Part D, but there was no MTD/RP2D. | mg/m^2 | NUMBER |
| PRIMARY | Number of Patients With Dose Limiting Toxicity (DLT) | Up to 21 days | All Toxicity evaluable patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Area Under the Concentration | Up to 21 days | All Toxicity evaluable patients. There were no data for Part A Dose Level 2, Part B Dose Level 3, and Part D Dose Level 1. | hr*ug/mL | MEDIAN |
| SECONDARY | Response Rate | Up to 2 years | Evaluable patients for response | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | ALK Status and Response to Crizotinib | up to 2 years | Neuroblastoma patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | MRD Status and Response to Crizotinib | Up to 2 years | Outcome Measure was specific to ALCL patients. There were zero ALCL patients, therefore, there are no data to report. | ||
| SECONDARY | ALK Expression for Crizotinib | Up to 7 days | ALK expression data were not and never will be collected. | ||
| SECONDARY | Acceptability of Crizotinib Capsule Formulation Palatability | Up to 1 week | All Toxicity evaluable patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Acceptability of Crizotinib Microsphere Formulation Palatability | Up to 1 week | All Toxicity evaluable patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group75
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) of Crizotinib | Part C (Crizotinib, Cyclophosphamide, Topotecan Hydrochloride) | 215 | mg/m^2 | ||
| Number of Patients With Dose Limiting Toxicity (DLT) | Part A Dose Level 1 | 2 | Participants | ||
| Number of Patients With Dose Limiting Toxicity (DLT) | Part A Dose Level 2 | 2 | Participants | ||
| Number of Patients With Dose Limiting Toxicity (DLT) | Part B Dose Level 1 | 0 | Participants | ||
| Number of Patients With Dose Limiting Toxicity (DLT) | Part B Dose Level 2 | 0 | Participants | ||
| Number of Patients With Dose Limiting Toxicity (DLT) | Part B Dose Level 3 | 2 | Participants | ||
| Number of Patients With Dose Limiting Toxicity (DLT) | Part C Dose Level 1 | 0 | Participants | ||
| Number of Patients With Dose Limiting Toxicity (DLT) | Part C Dose Level 2 | 1 | Participants | ||
| Number of Patients With Dose Limiting Toxicity (DLT) | Part C Dose Level 3 | 2 | Participants | ||
| Number of Patients With Dose Limiting Toxicity (DLT) | Part D Dose Level 1 | 3 | Participants |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow33
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 | 6 | |
| Overall Study | STARTED | Part A Dose Level 2 | 4 | |
| Overall Study | STARTED | Part B Dose Level 1 | 5 | |
| Overall Study | STARTED | Part B Dose Level 2 | 3 | |
| Overall Study | STARTED | Part B Dose Level 3 | 3 | |
| Overall Study | STARTED | Part C Dose Level 1 | 4 | |
| Overall Study | STARTED | Part C Dose Level 2 | 6 | |
| Overall Study | STARTED | Part C Dose Level 3 | 3 | |
| Overall Study | STARTED | Part D Dose Level 1 | 6 | |
| Overall Study | STARTED | Part D Dose Level 2 | 3 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events4,125
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 | 1 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A Dose Level 2 | 0 | 4 | |
| other | Abdominal distension | Gastrointestinal disorders | Part B Dose Level 1 | 0 | 5 | |
| other | Abdominal distension | Gastrointestinal disorders | Part B Dose Level 2 | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | Part B Dose Level 3 | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | Part C Dose Level 1 | 0 | 4 | |
| other | Abdominal distension | Gastrointestinal disorders | Part C Dose Level 2 | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part C Dose Level 3 | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | Part D Dose Level 1 | 1 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part D Dose Level 2 | 0 | 3 |
1 to 10 of 4,125Source ClinicalTrials.gov
See all 4,125 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A Dose Level 1 | 0 | 6 |
| Total, all-cause mortality | Part A Dose Level 2 | 0 | 4 |
| Total, all-cause mortality | Part B Dose Level 1 | 1 | 5 |
| Total, all-cause mortality | Part B Dose Level 2 | 0 | 3 |
| Total, all-cause mortality | Part B Dose Level 3 | 0 | 3 |
| Total, all-cause mortality | Part C Dose Level 1 | 1 | 4 |
| Total, all-cause mortality | Part C Dose Level 2 | 0 | 6 |
| Total, all-cause mortality | Part C Dose Level 3 | 0 | 3 |
| Total, all-cause mortality | Part D Dose Level 1 | 0 | 6 |
| Total, all-cause mortality | Part D Dose Level 2 | 0 | 3 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01606878
GET https://conductscience.org/api/trials/v1/NCT01606878/results?page=2