Participant flow

Study of MLN8237 in Participants With Advanced Hematological Malignancies · Source last updated 2019-05-31

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

groups

1. description

   Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.

   id

   FG000

   title

   Part 1: PIC Dose Escalation

2. description

   Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).

   id

   FG001

   title

   Part 1: ECT Dose Escalation

3. description

   Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).

   id

   FG002

   title

   Part 2: PTCL

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         18

      3. group Id

         FG002

         num Subjects

         0

      type

      Progressive Disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Symptomatic Deterioration

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Reason not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         28

      3. group Id

         FG002

         num Subjects

         2

      type

      STARTED

   2. achievements

      1. comment

         Completed = participants who completed study treatment.

         group Id

         FG000

         num Subjects

         0

      2. comment

         2 participants were ongoing as of primary completion date 27 Dec 2011 and have now completed.

         group Id

         FG001

         num Subjects

         2

      3. comment

         1 participant was ongoing as of primary completion date 27 Dec 2011 and has now completed.

         group Id

         FG002

         num Subjects

         1

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         26

      3. group Id

         FG002

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with a diagnosis of advanced hematological malignancies were enrolled 1 of 3 treatment groups, Part 1:alisertib powder-in capsule (PIC) 25 to 90 mg dose escalation cohort, Part 1: alisertib 30 to 50 mg enteric-coated tablet (ECT) dose escalation cohort, or Part 2: alisertib ECT 50 mg participants with peripheral T-cell lymphoma (PTCL).

recruitment Details

Participants took part in the study at 10 investigative sites in the United States from 11 July 2008 to19 October 2016.

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Preserved source evidence · Not medical advice