Participant flow

(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors · Source last updated 2022-06-21

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

groups

1. description

   Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

   id

   FG000

   title

   Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD

2. description

   Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

   id

   FG001

   title

   Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD

3. description

   Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

   id

   FG002

   title

   Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD

4. description

   Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

   id

   FG003

   title

   Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD

5. description

   Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. .

   id

   FG004

   title

   Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD

6. description

   Part 1: Patients received a starting dose of 300 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

   id

   FG005

   title

   Experimental: Part 1 Avapritinib (Formerly BLU-285) 300 mg QD

7. description

   Part 1: Patients received a starting dose of 400 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

   id

   FG006

   title

   Experimental: Part 1 Avapritinib (Formerly BLU-285) 400 mg QD

8. description

   Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

   id

   FG007

   title

   Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD

9. description

   Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. Patients received avapritinib in continuous 28 day cycles until discontinuation.

   id

   FG008

   title

   Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD

periods

1. drop Withdraws

   1. 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

         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

         0

      type

      did not complete >21 days of treatment

   2. 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

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      type

      Not Evaluable

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         7

      8. group Id

         FG007

         num Subjects

         3

      9. comment

         This group includes patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD. This group was not used to determine the MTD in Part 1

         group Id

         FG008

         num Subjects

         0

      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

         6

      7. group Id

         FG006

         num Subjects

         7

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      type

      Patients From Part 1 Included in the Part 2 Analyses

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         6

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         0

      type

      COMPLETED

   4. 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

         1

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Part 1 - Dose Determining Period

2. drop Withdraws

   1. 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

         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

         118

      type

      Disease Progression

   2. 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

         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

         49

      type

      Adverse Event

   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

         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

         12

      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

         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

         3

      type

      Administrative

   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

         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

         28

      type

      Sponsor Decision

   6. 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

         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

         1

      type

      Death

   7. 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

         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

         6

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. comment

         These patients are not included in Part 2 analyses

         group Id

         FG000

         num Subjects

         0

      2. comment

         These patients are not included in Part 2 analyses

         group Id

         FG001

         num Subjects

         0

      3. comment

         These patients are not included in Part 2 analyses

         group Id

         FG002

         num Subjects

         0

      4. comment

         These patients are not included in Part 2 analyses

         group Id

         FG003

         num Subjects

         0

      5. comment

         These patients are not included in Part 2 analyses

         group Id

         FG004

         num Subjects

         0

      6. comment

         Part 1 Only: 6 Patients from this group are included in the 300 or 400 mg QD group.

         group Id

         FG005

         num Subjects

         0

      7. comment

         Part 1 Only: 7 Patients from this group are included in the 300 or 400 mg QD group.

         group Id

         FG006

         num Subjects

         0

      8. comment

         These patients are not included in Part 2 analyses

         group Id

         FG007

         num Subjects

         0

      9. comment

         Includes 13 patients enrolled in Part 1 at a starting dose of 300 mg (n = 6) or 400 mg (n = 7) QD.

         group Id

         FG008

         num Subjects

         217

      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

      type

      COMPLETED

   3. 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

         217

      type

      NOT COMPLETED

   title

   Part 2 - Treatment

3. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      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

         1

      9. group Id

         FG008

         num Subjects

         6

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      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

         2

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         111

      type

      Death

   4. 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

         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

         6

      type

      Lost to Follow-up

   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

         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

         15

      type

      Withdrawal by Subject

   6. 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

         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

      9. group Id

         FG008

         num Subjects

         8

      type

      Physician Decision

   7. 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

         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

         1

      type

      Initiation of another therapy

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      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

         2

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         68

      type

      Sponsor Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         6

      6. comment

         These 6 patients are included in the 300 or 400 mg QD dose group

         group Id

         FG005

         num Subjects

         0

      7. comment

         These 7 patients are included in the 300 or 400 mg QD dose group

         group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         3

      9. comment

         Includes 13 patients enrolled in Part 1 at a starting dose of 300 mg (n = 6) or 400 mg (n = 7) QD.

         group Id

         FG008

         num Subjects

         217

      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

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         217

      type

      NOT COMPLETED

   title

   Part 1 and Part 2 End of Study

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Preserved source evidence · Not medical advice