Participant flow

Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma · Source last updated 2024-01-05

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

groups

1. description

   Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)

   id

   FG000

   title

   Part A Dose Level 1

2. description

   Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)

   id

   FG001

   title

   Part A Dose Level 2

3. description

   Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)

   id

   FG002

   title

   Part B Dose Level 1

4. description

   Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)

   id

   FG003

   title

   Part B Dose Level 2

5. description

   Patients receive 280 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)

   id

   FG004

   title

   Part B Dose Level 3

6. description

   Patients receive 165 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

   id

   FG005

   title

   Part C Dose Level 1

7. description

   Patients receive 215 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

   id

   FG006

   title

   Part C Dose Level 2

8. description

   Patients receive 280 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

   id

   FG007

   title

   Part C Dose Level 3

9. description

   Patients receive 165 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

   id

   FG008

   title

   Part D Dose Level 1

10. description

    Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

    id

    FG009

    title

    Part D Dose Level 2

11. description

    Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

    id

    FG010

    title

    Part PK Dose Level 2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         1

      10. group Id

          FG009

          num Subjects

          3

      11. group Id

          FG010

          num Subjects

          0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          1

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         1

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          2

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         6

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         6

      10. group Id

          FG009

          num Subjects

          3

      11. group Id

          FG010

          num Subjects

          3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         6

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         6

      10. group Id

          FG009

          num Subjects

          3

      11. group Id

          FG010

          num Subjects

          3

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

This is a dose-escalation study of crizotinib. Patients are assigned to Part A or Part B based on the treating physician's choice and availability of a reservation. After closure of Part A and Part B, patients are assigned to Part C and Part D.

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Preserved source evidence · Not medical advice