Participant flow

Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid Leukemia · Source last updated 2024-07-17

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

groups

1. description

   Participants with CMML received tipifarnib at a starting dose of 1200 mg, BID, for 7 days in alternating weeks (Days 1 to 7 and Days 15 to 21) in 28-day cycles.

   id

   FG000

   title

   KRAS/NRAS WT

2. description

   Participants with CMML received tipifarnib at a starting dose of 1200 mg, BID, for 7 days in alternating weeks (Days 1 to 7 and Days 15 to 21) in 28-day cycles.

   id

   FG001

   title

   KRAS/NRAS Mut

3. description

   Participants with CMML received tipifarnib at a starting dose of 1200 mg, BID, for 7 days in alternating weeks (Days 1 to 7 and Days 15 to 21) in 28-day cycles.

   id

   FG002

   title

   KRAS/NRAS Missing

4. description

   Participants with MDS/MPN received tipifarnib at a starting dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.

   id

   FG003

   title

   CXCR4/2 High

5. description

   Participants with MDS/MPN received tipifarnib at a starting dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.

   id

   FG004

   title

   CXCR4/2 Low

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      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

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         1

      type

      Permanent Withdrawal of Consent

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      type

      Protocol-defined Disease Progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      Study Terminated by Sponsor

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      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

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         4

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants w/ CMML were grouped by KRAS/NRAS status (wild type \[WT\], mutation \[Mut\], missing) \& received tipifarnib 1200mg twice daily (BID) for 7 days, alternating weeks (Days 1-7, 15-21) in 28-day cycles. Following PA3 participants received tipifarnib 400mg orally w/ food, BID for 21 days in 28-day cycles. Those w/ MDS/MPN were stratified by ratio of expression (high/low) between CXCR4 \& CXCR2 (CXCR4/2 ratio) receptors to receive tipifarnib 400mg orally, BID on Day 1-21 of each 28-day cycle.

recruitment Details

Participants affected by chronic myelomonocytic leukemia (CMML) and myelodysplastic syndromes (MDS)/myeloproliferative neoplasms (MPN) were recruited across 10 sites in the United States between January 2017 and November 2020.

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

Preserved source evidence · Not medical advice