Participant flow

Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors · Source last updated 2020-08-12

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

groups

1. description

   Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

   id

   FG000

   title

   Cohort 1: Rhabdomyosarcoma (RMS)

2. description

   Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

   id

   FG001

   title

   Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)

3. description

   Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

   id

   FG002

   title

   Cohort 3: Ewing Sarcoma/pPNET (Ewing)

4. description

   Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

   id

   FG003

   title

   Cohort 4 (Osteosarcoma)

5. description

   Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

   id

   FG004

   title

   Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)

6. description

   Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

   id

   FG005

   title

   Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)

7. description

   Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

   id

   FG006

   title

   Cohort 7 (Hepatoblastoma)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         8

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         5

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      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

         1

      7. group Id

         FG006

         num Subjects

         0

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         10

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         6

      comment

      All enrolled subjects who took 1 dose of medication included in mITT and Safety Sets

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         10

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         6

      comment

      All mITT subjects who had at least 1 PK sample analyzed

      type

      PK Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      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

         5

      comment

      PK subset (received powder suspension and had at least 1 non-predose extended PK sampling)

      type

      PKES Set

   4. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         3

      comment

      All mITT subjects who had valid biomarker samples analyzed

      type

      Biomarker Set

   5. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         5

      type

      Per Protocol Set (PP Set)

   6. 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

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         10

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

154 patients were planned to be enrolled in the study. A total of 57 patients were randomized and analyzed: cohort 1 (12), cohort 2 (11), cohort 3 (10), cohort 4 (10), cohort 5 (4), cohort 6 (4) and cohort 7 (6).

recruitment Details

This study was conducted at 30 centers in 7 countries: Canada (2), Czech Republic (1), France (1), Hungary (1), Slovakia (1), Spain (1) and USA (23).

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Preserved source evidence · Not medical advice