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NCT00621244 · OUTCOME

Number of Participants DLT in Arm 2 in Dose Escalation Phase

A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies · Source last updated 2021-01-05

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Cycle 1 (28-day treamtent cycle)

What was measured

Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.

Analysis population: MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat.

Groups in this outcome

Arm 2, Group X (30 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

Arm 2, Group X (45 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

Arm 2, Group X (60 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

Arm 2, Group X (80 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

Arm 2, Group Y (30 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

Arm 2, Group Y (45 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

Arm 2, Group Y (60 mg) - MTD

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

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

Analysis denominator · Participants

GroupSource count
Arm 2, Group X (30 mg)6
Arm 2, Group X (45 mg)7
Arm 2, Group X (60 mg)7
Arm 2, Group X (80 mg)8
Arm 2, Group Y (30 mg)1
Arm 2, Group Y (45 mg)6
Arm 2, Group Y (60 mg) - MTD13

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 2, Group X (30 mg)0Not reportedNot reportedNot reportedNot reported
Arm 2, Group X (45 mg)0Not reportedNot reportedNot reportedNot reported
Arm 2, Group X (60 mg)0Not reportedNot reportedNot reportedNot reported
Arm 2, Group X (80 mg)4Not reportedNot reportedNot reportedNot reported
Arm 2, Group Y (30 mg)0Not reportedNot reportedNot reportedNot reported
Arm 2, Group Y (45 mg)0Not reportedNot reportedNot reportedNot reported
Arm 2, Group Y (60 mg) - MTD3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      8
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      13
    units
    Participants
description
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
groups
  1. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    OG000
    title
    Arm 2, Group X (30 mg)
  2. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    OG001
    title
    Arm 2, Group X (45 mg)
  3. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    OG002
    title
    Arm 2, Group X (60 mg)
  4. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    OG003
    title
    Arm 2, Group X (80 mg)
  5. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
    id
    OG004
    title
    Arm 2, Group Y (30 mg)
  6. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
    id
    OG005
    title
    Arm 2, Group Y (45 mg)
  7. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
    id
    OG006
    title
    Arm 2, Group Y (60 mg) - MTD
param Type
NUMBER
population Description
MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat.
reporting Status
POSTED
time Frame
Cycle 1 (28-day treamtent cycle)
title
Number of Participants DLT in Arm 2 in Dose Escalation Phase
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice