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NCT01154816 · OUTCOME

Number of Participants With Overall Response

Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia · Source last updated 2020-05-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Patients
Interval / dispersion
Not reported
Time frame
From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.

What was measured

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.

Analysis population: Of the 118 enrolled patients, two were not evaluable for the primary outcome measure. Neither received protocol therapy. One was enrolled in arm 11, one was enrolled in Arm 1.

Groups in this outcome

Recurrent Neuroblastoma With Measurable Disease at Enrollment

Experimental: Arm 1

Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll

Experimental: Arm 2

Previously Treated Childhood Rhabdomyosarcoma

Experimental: Arm 3

Recurrent Osteosarcoma

Experimental: Arm 4

Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor

Experimental: Arm 5

Recurrent Childhood Soft Tissue Sarcoma

Experimental: Arm 6

Childhood Hepatoblastoma

Experimental: Arm 7

Recurrent Childhood Germ Cell Tumor

Experimental: Arm 8

Recurrent Wilms Tumor and Other Childhood Kidney Tumors

Experimental: Arm 9

Recurrent Childhood Acute Lympohblastic Leukemia

Experimental: Arm 10

Recurrent Childhood Acute Myeloid Leukemia

Experimental: Arm 11

Rhaboid Malignancy

Experimental: Arm 12

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Recurrent Neuroblastoma With Measurable Disease at Enrollment19
Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll12
Previously Treated Childhood Rhabdomyosarcoma10
Recurrent Osteosarcoma10
Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor10
Recurrent Childhood Soft Tissue Sarcoma8
Childhood Hepatoblastoma6
Recurrent Childhood Germ Cell Tumor7
Recurrent Wilms Tumor and Other Childhood Kidney Tumors10
Recurrent Childhood Acute Lympohblastic Leukemia10
Recurrent Childhood Acute Myeloid Leukemia10
Rhaboid Malignancy4

Reported measurements

Source class 1
Values in Patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Recurrent Neuroblastoma With Measurable Disease at Enrollment0Not reportedNot reportedNot reportedNot reported
Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll1Not reportedNot reportedNot reportedNot reported
Previously Treated Childhood Rhabdomyosarcoma0Not reportedNot reportedNot reportedNot reported
Recurrent Osteosarcoma0Not reportedNot reportedNot reportedNot reported
Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor0Not reportedNot reportedNot reportedNot reported
Recurrent Childhood Soft Tissue Sarcoma0Not reportedNot reportedNot reportedNot reported
Childhood Hepatoblastoma0Not reportedNot reportedNot reportedNot reported
Recurrent Childhood Germ Cell Tumor0Not reportedNot reportedNot reportedNot reported
Recurrent Wilms Tumor and Other Childhood Kidney Tumors1Not reportedNot reportedNot reportedNot reported
Recurrent Childhood Acute Lympohblastic Leukemia0Not reportedNot reportedNot reportedNot reported
Recurrent Childhood Acute Myeloid Leukemia0Not reportedNot reportedNot reportedNot reported
Rhaboid Malignancy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      8
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      7
    9. group Id
      OG008
      value
      10
    10. group Id
      OG009
      value
      10
    11. group Id
      OG010
      value
      10
    12. group Id
      OG011
      value
      4
    units
    Participants
description
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.
groups
  1. description
    Experimental: Arm 1
    id
    OG000
    title
    Recurrent Neuroblastoma With Measurable Disease at Enrollment
  2. description
    Experimental: Arm 2
    id
    OG001
    title
    Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll
  3. description
    Experimental: Arm 3
    id
    OG002
    title
    Previously Treated Childhood Rhabdomyosarcoma
  4. description
    Experimental: Arm 4
    id
    OG003
    title
    Recurrent Osteosarcoma
  5. description
    Experimental: Arm 5
    id
    OG004
    title
    Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor
  6. description
    Experimental: Arm 6
    id
    OG005
    title
    Recurrent Childhood Soft Tissue Sarcoma
  7. description
    Experimental: Arm 7
    id
    OG006
    title
    Childhood Hepatoblastoma
  8. description
    Experimental: Arm 8
    id
    OG007
    title
    Recurrent Childhood Germ Cell Tumor
  9. description
    Experimental: Arm 9
    id
    OG008
    title
    Recurrent Wilms Tumor and Other Childhood Kidney Tumors
  10. description
    Experimental: Arm 10
    id
    OG009
    title
    Recurrent Childhood Acute Lympohblastic Leukemia
  11. description
    Experimental: Arm 11
    id
    OG010
    title
    Recurrent Childhood Acute Myeloid Leukemia
  12. description
    Experimental: Arm 12
    id
    OG011
    title
    Rhaboid Malignancy
param Type
NUMBER
population Description
Of the 118 enrolled patients, two were not evaluable for the primary outcome measure. Neither received protocol therapy. One was enrolled in arm 11, one was enrolled in Arm 1.
reporting Status
POSTED
time Frame
From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.
title
Number of Participants With Overall Response
type
PRIMARY
unit Of Measure
Patients

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice