Trial · NCT00436852
ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
NCT00436852, Phase 2, Completed, Children's Oncology Group; results first posted 2014-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment. Trials, record NCT00436852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00436852
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
- NCT number
- NCT00436852
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Disseminated Neuroblastoma, Recurrent Neuroblastoma
- Interventions
- ABT-751, quality-of-life assessment
- First posted
- 2007-02-19
- Last updated
- 2019-07-17
- Results first posted
- 2014-02-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors | From time to enrollment to death due to any cause, assessed up to 5.1 years | Median time to progression observed on ABT-751, along with 95% confidence intervals. |
| Primary | 1-year Progression-free Survival | From the day of enrollment to the date of disease progression/recurrence , or the date of death (all causes of mortality) if disease progression/recurrence is not reached, assessed up to 1 yr. Pts were to be followed for 5 yrs after completion of therapy | PFS probabilities calculated using the Kaplan-Meier method, along 95% confidence intervals, separately for each stratum. |
| Secondary | Objective Response Rate | Duration of protocol therapy, up to 3 years | The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the percentage. Responders were defined as patients who achieved a best overall response of complete response (CR) or partial response (PR) at any time on the study including patients who achieved ≥PR and later had progressive disease or relapse. Response in patients with measurable disease will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or by Curie criteria for measuring response by MIBG scans in patients with evaluable disease by 123I-MIBG scan. Per RECIST: CR= Disappearance of all target lesions; PR= at least 30% decrease in the sum of the longest diameter of target lesions. Per Curie criteria: CR= complete resolution of all MIBG positive lesions; PR= resolution of at least one MIBG positive lesion with persistence of other MIBG positive lesions. |
| Secondary | Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0 | At baseline | The QOL score will be reverse linearly transformed to a 0-100 percentage point scale (0=100, 1=75, 2=50, 3=25, 4=0), with higher scores indicating better health-related quality of life, and the average of all 23 items will be calculated as the composite score. |
| Secondary | Percentage of Participants With Grade 3 or Higher Toxicity | From enrollment until 30 days after the end of protocol therapy | Percentage of patients with at least one Grade 3 or higher toxicity, as assessed by Common Terminology Criteria for Adverse Events version 3.0, will be tabulated. |
| Secondary | Pharmacokinetics of ABT-751: Cmax | After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose. | Values of the maximum observed concentration (Cmax) will be determined for the first dose.Descriptive statistics for these variables will be provided. |
| Secondary | Pharmacokinetics of ABT-751: Tmax | After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose. | Values of the time to maximum observed concentration (Tmax) will be determined for the first dose.Descriptive statistics for these variables will be provided. |
| Secondary | Pharmacokinetics of ABT-751: AUC | After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose. | Values of the area under concentration time curve \[AUC(0-∞)\] will be determined for the first dose. Descriptive statistics for these variables will be provided. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors | From time to enrollment to death due to any cause, assessed up to 5.1 years | The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable). | days | MEDIAN |
| PRIMARY | 1-year Progression-free Survival | From the day of enrollment to the date of disease progression/recurrence , or the date of death (all causes of mortality) if disease progression/recurrence is not reached, assessed up to 1 yr. Pts were to be followed for 5 yrs after completion of therapy | The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable). | percent probability | NUMBER |
| SECONDARY | Objective Response Rate | Duration of protocol therapy, up to 3 years | Patients who met study eligibility criteria and received at least one dose of oral ABT-751 were evaluable for the response analysis. | Percentage of patients | NUMBER |
| SECONDARY | Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0 | At baseline | Eligible patients with a QOL evaluation at baseline were included in the analysis. | Scores on a scale | MEDIAN |
| SECONDARY | Percentage of Participants With Grade 3 or Higher Toxicity | From enrollment until 30 days after the end of protocol therapy | All eligible patients who received at least 1 dose of ABT-751 were evaluable for toxicity and included in the analysis. | Percentage of patients | NUMBER |
| SECONDARY | Pharmacokinetics of ABT-751: Cmax | After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose. | All eligible patients from Group 1 (Disease Evaluable by I-MIBG Scintigraphy (ABT-751)) and Group 2 (Measurable Disease by CT or MRI Scan (ABT-751)) who received the first dose of ABT-751 and participated in the pharmacokinetic studies were included in the analysis and are presented as a single Group, as the interest was in both groups combined. | mg/ml | MEDIAN |
| SECONDARY | Pharmacokinetics of ABT-751: Tmax | After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose. | All eligible patients from Group 1 (Disease Evaluable by I-MIBG Scintigraphy (ABT-751)) and Group 2 (Measurable Disease by CT or MRI Scan (ABT-751)) who received the first dose of ABT-751 and participated in the pharmacokinetic studies were included in the analysis and are presented as a single Group, as the interest was in both groups combined. | hours | MEDIAN |
| SECONDARY | Pharmacokinetics of ABT-751: AUC | After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose. | All eligible patients from Group 1 (Disease Evaluable by I-MIBG Scintigraphy (ABT-751)) and Group 2 (Measurable Disease by CT or MRI Scan (ABT-751)) who received the first dose of ABT-751 and participated in the pharmacokinetic studies were included in the analysis and are presented as a single Group, as the interest was in both groups combined. | mg·hours/ml | MEDIAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 45 | 95% Confidence Interval 42 to 85 | days | |
| Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors | Measurable Disease by CT or MRI Scan (ABT-751) | 42 | 95% Confidence Interval 36 to 56 | days | |
| 1-year Progression-free Survival | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 19 | 95% Confidence Interval 7 to 31 | percent probability | |
| 1-year Progression-free Survival | Measurable Disease by CT or MRI Scan (ABT-751) | 7 | 95% Confidence Interval 0 to 15 | percent probability | |
| Objective Response Rate | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 12 | 95% Confidence Interval 2 to 21 | Percentage of patients | |
| Objective Response Rate | Measurable Disease by CT or MRI Scan (ABT-751) | 2 | 95% Confidence Interval 0 to 6 | Percentage of patients | |
| Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0 | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 80 | Full Range 44 to 99 | Scores on a scale | |
| Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0 | Measurable Disease by CT or MRI Scan (ABT-751) | 68 | Full Range 29 to 100 | Scores on a scale | |
| Percentage of Participants With Grade 3 or Higher Toxicity | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 75.0 | Percentage of patients | ||
| Percentage of Participants With Grade 3 or Higher Toxicity | Measurable Disease by CT or MRI Scan (ABT-751) | 72.3 | Percentage of patients |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 45 | |
| Overall Study | STARTED | Measurable Disease by CT or MRI Scan (ABT-751) | 47 | |
| Overall Study | COMPLETED | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 10 | |
| Overall Study | COMPLETED | Measurable Disease by CT or MRI Scan (ABT-751) | 2 | |
| Overall Study | NOT COMPLETED | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 35 | |
| Overall Study | NOT COMPLETED | Measurable Disease by CT or MRI Scan (ABT-751) | 45 |
Source ClinicalTrials.gov
Adverse events200
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 | Constipation | Gastrointestinal disorders | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 8 | 44 | 8 |
| other | Constipation | Gastrointestinal disorders | Measurable Disease by CT or MRI Scan (ABT-751) | 12 | 47 | 12 |
| other | Anorexia | Metabolism and nutrition disorders | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 7 | 44 | 7 |
| other | Anorexia | Metabolism and nutrition disorders | Measurable Disease by CT or MRI Scan (ABT-751) | 9 | 47 | 9 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 9 | 44 | 9 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Measurable Disease by CT or MRI Scan (ABT-751) | 14 | 47 | 14 |
| other | AST: AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 7 | 44 | 7 |
| other | AST: AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Measurable Disease by CT or MRI Scan (ABT-751) | 14 | 47 | 14 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 0 | 44 | 0 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Measurable Disease by CT or MRI Scan (ABT-751) | 12 | 47 | 12 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | ||
| Total, all-cause mortality | Measurable Disease by CT or MRI Scan (ABT-751) | ||
| Total, other adverse events | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 17 | 44 |
| Total, other adverse events | Measurable Disease by CT or MRI Scan (ABT-751) | 24 | 47 |
| Total, serious adverse events | Disease Evaluable by I-MIBG Scintigraphy (ABT-751) | 3 | 44 |
| Total, serious adverse events | Measurable Disease by CT or MRI Scan (ABT-751) | 4 | 47 |
Source ClinicalTrials.gov
Papers0
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 |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Disease Evaluable by I-MIBG Scintigraphy (ABT-751) vs Measurable Disease by CT or MRI Scan (ABT-751): serious adverse events |
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/NCT00436852
GET https://conductscience.org/api/trials/v1/NCT00436852/events?page=2