Participant flow

Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma · Source last updated 2020-06-09

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

groups

1. description

   Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.

   id

   FG000

   title

   Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID

2. description

   Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.

   id

   FG001

   title

   Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID

3. description

   Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.

   id

   FG002

   title

   Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID

4. description

   Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.

   id

   FG003

   title

   Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID

5. description

   Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.

   id

   FG004

   title

   Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID

6. description

   Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.

   id

   FG005

   title

   Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID

7. description

   Part B: Patients with ALK+ relapsed/refractory neuroblastoma

   id

   FG006

   title

   Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID

8. description

   Part C: Patients with ALK+ relapsed/refractory ALCL

   id

   FG007

   title

   Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID

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

         6

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         13

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         16

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         11

      8. group Id

         FG007

         num Subjects

         1

      type

      Lack of Efficacy

   3. reasons

      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

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         7

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         6

      type

      Physician Decision

   5. reasons

      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

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         2

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         23

      4. group Id

         FG003

         num Subjects

         12

      5. group Id

         FG004

         num Subjects

         38

      6. group Id

         FG005

         num Subjects

         11

      7. group Id

         FG006

         num Subjects

         14

      8. group Id

         FG007

         num Subjects

         10

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         20

      4. group Id

         FG003

         num Subjects

         11

      5. group Id

         FG004

         num Subjects

         37

      6. group Id

         FG005

         num Subjects

         11

      7. group Id

         FG006

         num Subjects

         14

      8. group Id

         FG007

         num Subjects

         10

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice