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NCT03593915 · OUTCOME

Tolerability of Alvocidib as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) as Observed in Cycle 1

A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS · Source last updated 2023-11-09

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Cycle 1 (28 days)

What was measured

The DLTs are defined as follows based on the NCI CTCAE v5.0: Must be at least possibly related to Alvocidib; Any Gr 4 nonhematologic toxicity; Gr 3 nonhematologic toxicity that does not resolve to ≤Gr 2 in 48 hours; Gr 3 diarrhea, mucositis, nausea, or vomiting will be considered dose limiting only if resolution to ≤Gr 2 requires \>7 days; and ≥Grade 3 creatinine elevation that does not resolve to \<G2 within 7 days.

Analysis population: Sponsor's decision to terminate further development of the alvocidib program. Data collection and analysis were therefore not conducted as planned.

Groups in this outcome

ALV-DEC: Cohort 1

Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 20mg/m2 (4 hr IVI)

ALV-DEC: Cohort 2

Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 30mg/m2 (4 hr IVI)

ALV-DEC: Cohort 3

Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 45mg/m2 (4 hr IVI)

ALV-DEC: Cohort 4

Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 60mg/m2 (4 hr IVI)

ALV-AZA: Cohort 5

Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 75mg/m2 as a 30-60 minute IVI.

ALV-AZA: Cohort 6

Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 90mg/m2 as a 30-60 minute IVI.

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

Analysis denominator · Participants

GroupSource count
ALV-DEC: Cohort 10
ALV-DEC: Cohort 20
ALV-DEC: Cohort 30
ALV-DEC: Cohort 40
ALV-AZA: Cohort 50
ALV-AZA: Cohort 60

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    units
    Participants
description
The DLTs are defined as follows based on the NCI CTCAE v5.0: Must be at least possibly related to Alvocidib; Any Gr 4 nonhematologic toxicity; Gr 3 nonhematologic toxicity that does not resolve to ≤Gr 2 in 48 hours; Gr 3 diarrhea, mucositis, nausea, or vomiting will be considered dose limiting only if resolution to ≤Gr 2 requires \>7 days; and ≥Grade 3 creatinine elevation that does not resolve to \<G2 within 7 days.
groups
  1. description
    Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 20mg/m2 (4 hr IVI)
    id
    OG000
    title
    ALV-DEC: Cohort 1
  2. description
    Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 30mg/m2 (4 hr IVI)
    id
    OG001
    title
    ALV-DEC: Cohort 2
  3. description
    Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 45mg/m2 (4 hr IVI)
    id
    OG002
    title
    ALV-DEC: Cohort 3
  4. description
    Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 60mg/m2 (4 hr IVI)
    id
    OG003
    title
    ALV-DEC: Cohort 4
  5. description
    Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 75mg/m2 as a 30-60 minute IVI.
    id
    OG004
    title
    ALV-AZA: Cohort 5
  6. description
    Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 90mg/m2 as a 30-60 minute IVI.
    id
    OG005
    title
    ALV-AZA: Cohort 6
population Description
Sponsor's decision to terminate further development of the alvocidib program. Data collection and analysis were therefore not conducted as planned.
reporting Status
POSTED
time Frame
Cycle 1 (28 days)
title
Tolerability of Alvocidib as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) as Observed in Cycle 1
type
PRIMARY

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

Preserved source evidence · Not medical advice