Trial · NCT02114229
Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors
NCT02114229, Phase 2, Active not recruiting, St. Jude Children's Research Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors. Trials, record NCT02114229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02114229
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors
- NCT number
- NCT02114229
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Malignant Rhabdoid Tumor, Atypical Teratoid Rhabdoid Tumor
- Interventions
- alisertib, methotrexate, cisplatin, carboplatin, cyclophosphamide, etoposide, topotecan, vincristine, Surgical resection, Radiation therapy
- First posted
- 2014-04-15
- Last updated
- 2026-09-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained response rate of pediatric participants with recurrent or refractory AT/RT treated with alisertib (stratum A1) | Within 30 weeks after start of alisertib therapy | Efficacy endpoint: Objective responses (partial response + complete response) that occur within the first 10 courses (approximately 30 weeks) of treatment which are sustained for an additional 2 courses (approximately 6 weeks) and/or 12-week disease stabilization as confirmed by MRI are considered a success in the statistical analysis of the efficacy endpoint. |
| Primary | Sustained response rate of pediatric participants with recurrent or refractory MRT treated with alisertib (stratum A2) | Within 30 weeks after start of alisertib therapy | Efficacy endpoint: Objective responses (partial response + complete response) that occur within the first 10 courses (approximately 30 weeks) of treatment which are sustained for an additional 2 courses (approximately 6 weeks) and/or 12-week disease stabilization as confirmed by MRI are considered a success in the statistical analysis of the efficacy endpoint. |
| Primary | 3-year progression free survival rate (stratum B1) | Up to 3 years after the last enrolled patient starts therapy | Participants with AT/RT who are younger than 36 months of age at diagnosis with no metastatic disease treated with alisertib in sequence with induction and consolidation chemotherapy will be included for this analysis. Progression free survival will be measured from the date of diagnosis to the earliest date of disease progression, death, second malignancy, or the date of last follow-up. |
| Primary | 1-year progression free survival rate (stratum B2) | Up to 1 year after the last enrolled patient starts therapy | Participants with AT/RT who are younger than 36 months of age at diagnosis with metastatic disease treated with alisertib in sequence with induction and consolidation chemotherapy will be included for this analysis. Progression free survival will be measured from the date of diagnosis to the earliest date of disease progression, death, second malignancy, or the date of last follow-up. |
| Primary | 3-year progression free survival rate (stratum C1) | Up to 3 years after the last enrolled patient starts therapy | Participants with AT/RT who are 3 years of age or older at diagnosis with no metastatic disease and gross total resection or near total resection treated with alisertib in sequence with radiation therapy and consolidation chemotherapy will be included for this analysis. Progression free survival will be measured from the date of diagnosis to the earliest date of disease progression, death, second malignancy, or the date of last follow-up. |
| Primary | 1-year progression free survival rate (stratum C2) | Up to 1-year after the last enrolled patient starts therapy | Participants with AT/RT who are 3 years of age or older at diagnosis with metastatic or residual disease treated with alisertib in sequence with radiation therapy and consolidation chemotherapy will be included for this analysis. Progression free survival will be measured from the date of diagnosis to the earliest date of disease progression, death, second malignancy, or the date of last follow-up |
| Primary | Single dose and steady state pharmacokinetics and pharmacodynamics of alisertib | Treatment Cycle 1 on days 1 and 7 | Single dose pharmacokinetic studies will be performed on cycle 1 day 1 and serial plasma samples will be collected at: pre-dose and 0.5, 1, 1.5, 4, 6 (± 0.5), 24 (± 4), and 48 (± 6) hours after the first dose. Steady-state pharmacokinetic studies will be performed on cycle 1 day 7 and serial plasma samples will be collected at: pre-dose, and 1.5, 4, and 24 (±4) hours after the dose. The analysis for the pharmacokinetic primary objective of this study will be conducted using compartmental and noncompartmental approaches. The noncompartmental analysis will provide an estimate of the maximum concentration (Cmax), minimum concentration (Cmin), area under the concentration time curve (AUC), and apparent oral clearance (CL/F). Compartmental analysis will be performed using nonlinear mixed effects modeling and estimated pharmacokinetic parameters may include absorption rate constant (ka), apparent oral clearance (CL/F), and apparent volume of distribution (Vd/F). |
| Secondary | Duration of objective response by stratum A1 and A2 | At the time of tumor assessment (up to 5 years) | The duration of objective response will be measured from the initial scan documenting complete or partial response to the earlier of documented progression or death on study. Duration of objective response will be censored at the last tumor assessment date for patients without disease progression. |
| Secondary | 1-year progression-free survival (PFS) by stratum A1 and A2 | Up to 5 years after the last enrolled patient starts treatment. | Progression-free survival (PFS) will be measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death. Duration of PFS will be censored at the last tumor assessment date for patients without disease progression. |
| Secondary | 5-year Progression-free survival (PFS) rate in patients with newly diagnosed AT/RT (strata B1, B2, B3, C1, C2) | Up to 5 years after the last enrolled patient starts treatment. | PFS will be measured from the date of diagnosis to the earliest date of disease progression, death, second malignancy, or the date of last follow-up. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT02114229
GET https://conductscience.org/api/trials/v1/NCT02114229/registered