Trial · NCT00939770
Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
NCT00939770, Phase 1, Phase 2, Completed, Children's Oncology Group; results first posted 2020-05-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma. Trials, record NCT00939770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00939770
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
- NCT number
- NCT00939770
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Neuroblastoma, Refractory Anaplastic Large Cell Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Neuroblastoma
- Interventions
- Crizotinib, Laboratory Biomarker Analysis, Pharmacological Study, Questionnaire Administration
- First posted
- 2009-07-15
- Last updated
- 2020-06-09
- Results first posted
- 2020-05-05
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 and Recommended Phase 2 Dose of Crizotinib | 28 days | The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event (AE) reporting. The MTD/RP2D is defined as the maximum dose at which fewer than one-third of patients experience dose limiting toxicity. |
| Primary | Number of Participants With Toxicities of Crizotinib | Up to 30 days post-treatment | The descriptions and grading scales found in the revised NCI CTCAE version 4.0 will be utilized for AE reporting. |
| Primary | Steady State C Max of Crizotinib | Cycle 1 (day 15- 28) pre-dose, 1, 2,4, 6-8 hours post dose | Mean with standard deviation of peak of serum concentration curve at steady state by dose level. |
| Primary | Steady State C Average of Crizotinib | Cycle 1 (day 15-28) pre-dose, 1, 2, 4, 6-8 hours post-dose | Mean with standard deviation of average serum concentration curve at steady state by dose level. |
| Primary | Steady State AUC of Crizotinib | Cycle 1 (day 15-28) pre-dose, 1, 2, 4, 6-8 hours post-dose | Mean with standard deviation of area under the serum concentration curve at steady state by dose level. |
| Primary | Steady State Clearance of Crizotinib | Cycle 1 (day 15-28) pre-dose, 1, 2, 4, 6-8 hour post-dose | Mean with standard deviation of the elimination of crizotinib at steady state by dose level. |
| Secondary | Number of Participants (Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma (ALCL))With Response to Crizotinib | Up to 8 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Number of Participants (Relapsed or Refractory Neuroblastoma or Anaplastic Large Cell Lymphoma (ALCL)) With Response to Crizotinib | Up to 8 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Number of Participants With Minimum Residual Disease (MRD) | Up to 8 years | MRD status will be reported descriptively. The relationship between MRD status and clinical response to treatment will be examined in children with ALCL. |
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 and Recommended Phase 2 Dose of Crizotinib | 28 days | Phase 1 patients | mg/m²/dose BID | NUMBER |
| PRIMARY | Number of Participants With Toxicities of Crizotinib | Up to 30 days post-treatment | All patients included in analysis | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Steady State C Max of Crizotinib | Cycle 1 (day 15- 28) pre-dose, 1, 2,4, 6-8 hours post dose | Steady state PK sampling was not performed during enrollment on dose level 1 or 2. In Phase 2, PK was optional and for those who consented data is included with dose level 5. Steady state PK samples were obtained on a day between day 15 and 28 of cycle 1, pre-dose, 1, 2, 4, 6-8 h post-dose | ng/mL | MEAN |
| PRIMARY | Steady State C Average of Crizotinib | Cycle 1 (day 15-28) pre-dose, 1, 2, 4, 6-8 hours post-dose | Steady state PK sampling was not performed during enrollment on dose level 1 or 2. In Phase 2, PK was optional and for those who consented data is included with dose level 5. Steady state PK samples were obtained on a day between day 15 and 28 of cycle 1, pre-dose, 1, 2, 4, 6-8 h post-dose | ng/mL | MEAN |
| PRIMARY | Steady State AUC of Crizotinib | Cycle 1 (day 15-28) pre-dose, 1, 2, 4, 6-8 hours post-dose | Steady state PK sampling was not performed during enrollment on dose level 1 or 2. In Phase 2, PK was optional and for those who consented data is included with dose level 5. Steady state PK samples were obtained on a day between day 15 and 28 of cycle 1, pre-dose, 1, 2, 4, 6-8 h post-dose | ng•h/mL | MEAN |
| PRIMARY | Steady State Clearance of Crizotinib | Cycle 1 (day 15-28) pre-dose, 1, 2, 4, 6-8 hour post-dose | Steady state PK sampling was not performed during enrollment on dose level 1 or 2. In Phase 2, PK was optional and for those who consented data is included with dose level 5. Steady state PK samples were obtained on a day between day 15 and 28 of cycle 1, pre-dose, 1, 2, 4, 6-8 h post-dose. | mL/min/m2 | MEAN |
| SECONDARY | Number of Participants (Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma (ALCL))With Response to Crizotinib | Up to 8 years | Part A Participants with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants (Relapsed or Refractory Neuroblastoma or Anaplastic Large Cell Lymphoma (ALCL)) With Response to Crizotinib | Up to 8 years | Part B and Part C participants with relapsed or refractory neuroblastoma or anaplastic large cell lymphoma (ALCL) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Minimum Residual Disease (MRD) | Up to 8 years | MRD Patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum-tolerated Dose and Recommended Phase 2 Dose of Crizotinib | Part A | 280 | mg/m²/dose BID | ||
| Number of Participants With Toxicities of Crizotinib | Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID | 6 | Participants | ||
| Number of Participants With Toxicities of Crizotinib | Phase 1: Part A:PF-02341066 130 mg/m²/Dose BID | 7 | Participants | ||
| Number of Participants With Toxicities of Crizotinib | Phase 1: Part A:PF-02341066 165 mg/m²/Dose BID | 23 | Participants | ||
| Number of Participants With Toxicities of Crizotinib | Phase 1: Part A:PF-02341066 215 mg/m²/Dose BID | 11 | Participants | ||
| Number of Participants With Toxicities of Crizotinib | Phase 1: Part A:PF-02341066 280 mg/m²/Dose BID | 38 | Participants | ||
| Number of Participants With Toxicities of Crizotinib | Phase 1: Part A: PF-02341066 365 mg/m²/Dose BID | 11 | Participants | ||
| Number of Participants With Toxicities of Crizotinib | Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID | 14 | Participants | ||
| Number of Participants With Toxicities of Crizotinib | Phase 2:Part C: PF-02341066 280 mg/m2/Dose BID | 10 | Participants | ||
| Steady State C Max of Crizotinib | Dose Level 3 | 294 | Standard Deviation 0 | ng/mL |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID | 6 | |
| Overall Study | STARTED | Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID | 8 | |
| Overall Study | STARTED | Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID | 23 | |
| Overall Study | STARTED | Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID | 12 | |
| Overall Study | STARTED | Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID | 38 | |
| Overall Study | STARTED | Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID | 11 | |
| Overall Study | STARTED | Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID | 14 | |
| Overall Study | STARTED | Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID | 10 | |
| Overall Study | COMPLETED | Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID | 1 | |
| Overall Study | COMPLETED | Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events3,280
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 | Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID | 1 | 8 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID | 3 | 23 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID | 0 | 12 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID | 5 | 38 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID | 1 | 11 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID | 3 | 14 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID | 0 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID | 2 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID | 1 | 8 |
1 to 10 of 3,280Source ClinicalTrials.gov
See all 3,280 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID | 0 | 6 |
| Total, all-cause mortality | Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID | 0 | 8 |
| Total, all-cause mortality | Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID | 3 | 23 |
| Total, all-cause mortality | Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID | 2 | 12 |
| Total, all-cause mortality | Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID | 2 | 38 |
| Total, all-cause mortality | Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID | 1 | 11 |
| Total, all-cause mortality | Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID | 1 | 14 |
| Total, all-cause mortality | Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID | 0 | 10 |
| Total, other adverse events | Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID | 6 | 6 |
| Total, other adverse events | Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID | 8 | 8 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers4
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID vs Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID: Number of Participants (Relapsed or Refractory Neuroblastoma or Anaplastic Large Cell Lymphoma (ALCL)) With Response to Crizotinib |
Source Trial comparisons
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/NCT00939770
GET https://conductscience.org/api/trials/v1/NCT00939770/results?page=2