Participant flow

Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer · Source last updated 2016-06-17

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

groups

1. description

   • MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.

   id

   FG000

   title

   MM-398 (Arm A)

2. description

   * 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.

   id

   FG001

   title

   5-FU + Leucovorin (Arm B)

3. description

   * MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2. * 5-FU 2400 mg/m2 IV over 46-hours, and * Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks

   id

   FG002

   title

   MM-398 + 5-FU + Leucovorin (Arm C)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         77

      2. group Id

         FG001

         num Subjects

         83

      3. group Id

         FG002

         num Subjects

         57

      type

      Lack of Efficacy

   2. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         11

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         2

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         4

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         14

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         13

      type

      Clinical Deterioration

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Sponsor Decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         1

      type

      Other

   milestones

   1. achievements

      1. comment

         Started = Intent to Treat Population and includes all randomized participants

         group Id

         FG000

         num Subjects

         151

      2. group Id

         FG001

         num Subjects

         149

      3. group Id

         FG002

         num Subjects

         117

      type

      STARTED

   2. achievements

      1. comment

         Treated population: Patients who received at least 1 dose of study drug.

         group Id

         FG000

         num Subjects

         147

      2. group Id

         FG001

         num Subjects

         134

      3. comment

         2 randomized Arm C patients did not receive study drug. 1 patient each in A and B received Arm C.

         group Id

         FG002

         num Subjects

         117

      type

      Treated Population

   3. achievements

      1. comment

         Completed = Subjects remaining on treatment at the time of the primary analysis data cut off.

         group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         14

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         148

      2. group Id

         FG001

         num Subjects

         143

      3. group Id

         FG002

         num Subjects

         103

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

All patients were screened for UGT1A1\*28 allele at baseline.

recruitment Details

Patients were randomized over a period of 1.9 years starting from 2012-01-11 to 2013-09-11. The study was initially a two-arm study with MM-398 monotherapy and 5-FU/LV control (protocol version 1) . A third arm of MM-398+5-FU/LV was added later (protocol version 2).

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Preserved source evidence · Not medical advice