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NCT02114229 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors

A Phase 2 study of Malignant Rhabdoid Tumor and Atypical Teratoid Rhabdoid Tumor, sponsored by St. Jude Children's Research Hospital.

Active
Registry status
Phase 2
Development phase
125
Enrollment target
9
Study locations

NCT02114229 is a Phase 2 study of Malignant Rhabdoid Tumor and Atypical Teratoid Rhabdoid Tumor that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 125 participants, above the 23-participant average among 6 other Malignant Rhabdoid Tumor trials with a reported enrollment target (443% higher). The trial reports 9 study locations across 8 states.

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The verdict

NCT02114229, a Phase 2 study of Malignant Rhabdoid Tumor and Atypical Teratoid Rhabdoid Tumor, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
125 participants
Enrollment target
9
Study locations

Study Summary

This study incorporates alisertib, the small-molecule inhibitor of Aurora A activity, in the treatment of patients younger than 22 years of age. Patients with recurrent or refractory AT/RT or MRT will receive alisertib as a single agent. Patients with newly diagnosed AT/RT will receive alisertib as part of age- and risk-adapted chemotherapy. Radiation therapy will be given to children ≥12 months of age. Patients with AT/RT and concurrent extra-CNS MRT are eligible. Alisertib will be administered as a single agent on days 1-7 of each 21-day cycle in all recurrent patients enrolled on Stratum A. For the patients on the newly diagnosed strata (B, C or D), alisertib will be administered in sequence with chemotherapy and radiotherapy. This study has 3 primary strata: (A) children with recurrent/progressive AT/RT or extra-CNS MRT, (B) children \< 36 months-old with newly diagnosed AT/RT, (C) children \> 36 months old with newly diagnosed AT/RT. Children with concurrent MRT will be treated according to age and risk stratification schemes outlined for strata B and C and will have additional treatment for local control. Children with synchronous AT/RT will be treated with age and CNS risk-appropriate therapy, and also receive surgery and/or radiation therapy for local control of the non-CNS tumor. PRIMARY OBJECTIVES * To estimate the sustained objective response rate and disease stabilization in pediatric patients with recurrent or progressive AT/RT (atypical teratoid rhabdoid tumor in the CNS) (Stratum A1) treated with alisertib and to determine if the response is sufficient to merit continued investigation of alisertib in this population. * To estimate the sustained objective response rate and disease stabilization in pediatric patients with recurrent or progressive extra-CNS MRT (malignant rhabdoid tumor outside the CNS) (Stratum A2) treated with alisertib and to determine if the response is sufficient to merit continued investigation of alisertib in this population.

Conditions Studied

Malignant Rhabdoid Tumor Atypical Teratoid Rhabdoid Tumor

Interventions

  • DRUG cisplatin
  • DRUG carboplatin
  • DRUG cyclophosphamide
  • DRUG alisertib
  • DRUG methotrexate

Study Locations (9)

California

  • Lucille Packard Children's Hospital at Stanford University Medical Center - Palo Alto
  • Rady Children's Hospital - San Diego

Colorado

  • Children's Hospital Colorado - Aurora

District of Columbia

  • Children's National Medical Center - Washington D.C.

Florida

  • UF Cancer Center at Orlando Health - Orlando

Georgia

  • Children's Healthcare of Atlanta - Atlanta

Minnesota

  • Children's Hospital and Clinics of Minnesota - Minneapolis

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Texas

  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2014-05-14
Est. Completion 2027-09
Phase Phase 2

Sponsor

St. Jude Children's Research Hospital

410 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02114229

The ClinicalTrials.gov registry entry for NCT02114229 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 23-participant average among 6 other Malignant Rhabdoid Tumor trials with a reported enrollment target (443% higher). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Malignant Rhabdoid Tumor appearing as the primary indexed condition, and to 5 interventions - of which cisplatin is the first listed.

NCT02114229 reports 9 study locations spanning 8 distinct geographic areas - top geographies include California, Colorado, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT02114229 about?

NCT02114229 is a clinical study titled "Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors". This study incorporates alisertib, the small-molecule inhibitor of Aurora A activity, in the treatment of patients younger than 22 years of age. Patients with recurrent or refractory AT/RT or MRT will receive alisertib as a single agent. Patients with newly diagnosed AT/RT will receive alisertib as ...

What is the current status of trial NCT02114229?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2014-05-14. Estimated completion is 2027-09.

What conditions does trial NCT02114229 study?

This clinical trial studies the following conditions: Malignant Rhabdoid Tumor, Atypical Teratoid Rhabdoid Tumor.

What interventions are being tested in trial NCT02114229?

The interventions under investigation include: cisplatin (DRUG), carboplatin (DRUG), cyclophosphamide (DRUG), alisertib (DRUG), methotrexate (DRUG).

Who is sponsoring clinical trial NCT02114229?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02114229 being conducted?

This trial has 9 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.