Brief Summary

This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

118

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Feb 2011

Longer than P75 for phase_2

Geographic Reach

2 countries

105 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8.4 years study duration

First Submitted

Initial submission to the registry

June 30, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed

7 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

June 5, 2017

Completed

2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed

Last Updated

May 13, 2020

Status Verified

September 1, 2017

Enrollment Period

4.9 years

First QC Date

June 30, 2010

Results QC Date

July 28, 2016

Last Update Submit

April 29, 2020

Conditions

Hepatoblastoma Previously Treated Childhood Rhabdomyosarcoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Kidney Neoplasm Recurrent Childhood Malignant Germ Cell Tumor Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Soft Tissue Sarcoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Neuroblastoma Recurrent Osteosarcoma

Outcome Measures

Primary Outcomes (1)

Number of Participants With Overall Response
For patients with recurrent solid tumors a patient who experienced a complete or partial response according to RECIST version 1.1 criteria is considered a responder. For patients with recurrent acute lymphoblastic leukemia a patient who experiences a bone marrow evaluation with \< 5% blast cells on morphological evaluation of bone marrow will be considered a responder. For patients with recurrent acute myelogenous leukemia a patient who experiences a complete remission or complete remission with partial recovery of platelet count according to the AML International Working Group Criteria will be considered a responder.
From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.

Secondary Outcomes (7)

Number of Patients Cycles With Grade 3 or Higher Adverse Event
Up to 24 months
Serum Concentration of Alisertib Prior to the First Day of Administration
day 1 of protocol therapy
Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration
day 1 of protocol therapy
Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration
day 1 of protocol therapy
Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration
day 1 of protocol therapy
+2 more secondary outcomes

Study Arms (12)

Arm I (neuroblastoma- measurable)

EXPERIMENTAL

Patients with measurable neuroblastoma receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.