Trial · NCT02114229
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | 5-year Overall survival (OS) rate in patients with newly diagnosed AT/RT (strata B1, B2, B3, C1, C2) | Up to 5-years after the last patient starts protocol treatment | OS will be measured from the date of diagnosis to the date of death or date of last contact. |
| Secondary | Proportion of local and distant failure in strata B1, B2, B3, C1 and C2 | Up to 5 years after the last patient starts therapy | Local control relative to primary site radiotherapy, with criteria for infield, marginal or distant failure will be reported descriptively. Patterns of failure and sites of progression of disease will be described separately in each study stratum. Summary statistics of follow-up time and corresponding 95% confidence intervals will be provided. Point estimates of percentages of local and distant failures and exact confidence interval estimates will be constructed as well. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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