Participant flow

Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma · Source last updated 2022-12-13

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

groups

1. description

   Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

   id

   FG000

   title

   Part A: CC-223 7.5 mg

2. description

   Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

   id

   FG001

   title

   Part A: CC-223 15 mg

3. description

   Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

   id

   FG002

   title

   Part A: CC-223 30 mg

4. description

   Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

   id

   FG003

   title

   Part A: CC-223 45 mg

5. description

   Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

   id

   FG004

   title

   Part A: CC-223 60 mg

6. description

   Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.

   id

   FG005

   title

   Part B: Non-small Cell Lung Cancer (NSCLC)

7. description

   Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.

   id

   FG006

   title

   Part B: Glioblastoma Multiforme (GBM)

8. description

   Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.

   id

   FG007

   title

   Part B: Hepatocellular Carcinoma (HCC)

9. description

   Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.

   id

   FG008

   title

   Part B: Neuroendocrine Tumor (NET)

10. description

    Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.

    id

    FG009

    title

    Part B: Diffuse Large B-cell Lymphoma (DLBCL)

11. description

    Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.

    id

    FG010

    title

    Part B: Multiple Myeloma (MM)

12. description

    Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.

    id

    FG011

    title

    Part B: Hormone Receptor Positive Breast Cancer (HRPBC)

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

         1

      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

      12. group Id

          FG011

          num Subjects

          0

      type

      Protocol Violation

   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

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      type

      Lost to Follow-up

   3. 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

         0

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          1

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      type

      Death

   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

         1

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         9

      10. group Id

          FG009

          num Subjects

          1

      11. group Id

          FG010

          num Subjects

          1

      12. group Id

          FG011

          num Subjects

          0

      type

      Withdrawal by Subject

   5. 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

         2

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         12

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         14

      9. group Id

         FG008

         num Subjects

         8

      10. group Id

          FG009

          num Subjects

          6

      11. group Id

          FG010

          num Subjects

          3

      12. group Id

          FG011

          num Subjects

          7

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         10

      7. group Id

         FG006

         num Subjects

         10

      8. group Id

         FG007

         num Subjects

         21

      9. group Id

         FG008

         num Subjects

         18

      10. group Id

          FG009

          num Subjects

          12

      11. group Id

          FG010

          num Subjects

          10

      12. group Id

          FG011

          num Subjects

          8

      type

      Disease progression

   7. 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

         1

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         6

      9. group Id

         FG008

         num Subjects

         10

      10. group Id

          FG009

          num Subjects

          8

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          2

      type

      Other reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         7

      6. group Id

         FG005

         num Subjects

         26

      7. group Id

         FG006

         num Subjects

         13

      8. group Id

         FG007

         num Subjects

         53

      9. group Id

         FG008

         num Subjects

         47

      10. group Id

          FG009

          num Subjects

          28

      11. group Id

          FG010

          num Subjects

          14

      12. group Id

          FG011

          num Subjects

          17

      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

      12. group Id

          FG011

          num Subjects

          0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         7

      6. group Id

         FG005

         num Subjects

         26

      7. group Id

         FG006

         num Subjects

         13

      8. group Id

         FG007

         num Subjects

         53

      9. group Id

         FG008

         num Subjects

         47

      10. group Id

          FG009

          num Subjects

          28

      11. group Id

          FG010

          num Subjects

          14

      12. group Id

          FG011

          num Subjects

          17

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice