Participant flow

A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase · Source last updated 2019-03-15

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

groups

1. description

   Participants receiving 50 mg of LDK378

   id

   FG000

   title

   LDK378 50 mg

2. description

   Participants receiving 100 mg of LDK378

   id

   FG001

   title

   LDK378 100 mg

3. description

   Participants receiving 200 mg of LDK378

   id

   FG002

   title

   LDK378 200 mg

4. description

   Participants receiving 300 mg of LDK378

   id

   FG003

   title

   LDK378 300 mg

5. description

   Participants receiving 400 mg of LDK378

   id

   FG004

   title

   LDK378 400 mg

6. description

   Participants receiving 500 mg of LDK378

   id

   FG005

   title

   LDK378 500 mg

7. description

   Participants receiving 600 mg of LDK378

   id

   FG006

   title

   LDK378 600 mg

8. description

   Participants receiving 700 mg of LDK378

   id

   FG007

   title

   LDK378 700 mg

9. description

   Participants receiving 750 mg of LDK378.

   id

   FG008

   title

   LDK378 750 mg

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

         2

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         28

      type

      Adverse Event

   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

         1

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         12

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         13

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         6

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         139

      type

      Disease Progression

   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

         1

      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

         36

      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

         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

         1

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         39

      type

      Administrative problems

   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

      Lost to Follow-up

   milestones

   1. achievements

      1. comment

         Started = Full Analysis Set and Safety Set

         group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         14

      6. group Id

         FG005

         num Subjects

         10

      7. group Id

         FG006

         num Subjects

         10

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         255

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         12

      6. group Id

         FG005

         num Subjects

         10

      7. group Id

         FG006

         num Subjects

         9

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         246

      type

      Non-Small Cell Lung Cancer (NSCLC)

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         14

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         10

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         8

      type

      Dose-Determining Set (DDS)

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      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

         2

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         0

      9. comment

         Small number of patients at 750 mg - non-NSCLC, assessment limited, not included in efficacy tables

         group Id

         FG008

         num Subjects

         9

      type

      Non-NSCLC

   5. achievements

      1. comment

         Completed - see explanation in Recruitment Details.

         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

   6. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         14

      6. group Id

         FG005

         num Subjects

         10

      7. group Id

         FG006

         num Subjects

         10

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         255

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 304 patients were treated with LDK378 in the study, including 59 patients from the dose-escalation phase (including 10 patients at 750 mg) and 245 patients from the expansion phase treated at LDK378 750 mg.

recruitment Details

Study was considered completed when all patients discontinued ceritinib treatment, \& all required follow-up was completed or patient died, was lost to follow-up or withdrew their consent to further participate in study or last patient on treatment was enrolled to a separate protocol to continue receiving ceritinib treatment, whichever came first.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice