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NCT00555906 · OUTCOME

Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma. · Source last updated 2015-03-19

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

Measure
NUMBER
Unit
milligram (mg)
Interval / dispersion
Not reported
Time frame
Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B

What was measured

RP2D was determined based on the MTD, safety and tolerability profile of the study treatment.

Analysis population: DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.

Groups in this outcome

Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)

Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)

Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)9
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)12

Reported measurements

Source class 1
Values in milligram (mg) · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)NANot reportedNot reportedNot reportedBoth palbociclib 75 mg+bortezomib+dexamethasone and palbociclib 100 mg+bortezomib+dexamethasone had DLT \>1/6, hence no RP2D was selected from these 2 dosing groups.
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Both palbociclib 75 mg+bortezomib+dexamethasone and palbociclib 100 mg+bortezomib+dexamethasone had DLT \>1/6, hence no RP2D was selected from these 2 dosing groups.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      12
    units
    Participants
description
RP2D was determined based on the MTD, safety and tolerability profile of the study treatment.
groups
  1. description
    Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    OG000
    title
    Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
  2. description
    Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    OG001
    title
    Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
param Type
NUMBER
population Description
DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.
reporting Status
POSTED
time Frame
Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B
title
Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1
type
PRIMARY
unit Of Measure
milligram (mg)

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Preserved source evidence · Not medical advice