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NCT02264613 · OUTCOME

Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas

ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas · Source last updated 2026-01-13

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

Measure
MEDIAN
Unit
hour
Interval / dispersion
Full Range
Time frame
8 weeks

What was measured

Time of Peak Plasma Concentration (Tmax)

Analysis population: The Pharmacokinetic Analysis Population included all subjects who received at least one dose of ALRN-6924 with sufficient plasma sample data to assess PK parameters, and with no major protocol violations. Plasma samples for subjects in the Combination With Palbociclib Expansion arm were collected but will not be processed or analyzed due to a protocol-level decision for this expansion arm to discontinue pharmacokinetic data collection.

Groups in this outcome

Dose Regimen A (DR-A) Escalation (0.16 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (0.32 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (0.64 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (0.32 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (0.53 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (0.80 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (1.10 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (1.50 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (2.00 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen B (DR-B) Escalation (2.70 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen A (DR-A) PTCL Expansion

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

Dose Regimen C (DR-C) PTCL Expansion

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

Combination With Palbociclib Expansion

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

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

Analysis denominator · Participants

GroupSource count
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)5
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)3
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)4
Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation3
Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation6
Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation9
Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation11
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)3
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)5
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)3
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)4
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)4
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)5
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)6
Dose Regimen A (DR-A) PTCL Expansion21
Dose Regimen C (DR-C) PTCL Expansion16
Combination With Palbociclib Expansion0

Reported measurements

Source class 1
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)0.03Not reported0.000.52Not reported
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)0.13Not reported0.070.50Not reported
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)0.04Not reported0.020.47Not reported
Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation0.04Not reported0.020.07Not reported
Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation0.29Not reported0.001.00Not reported
Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation0.12Not reported0.000.65Not reported
Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation0.06Not reported0.031.00Not reported
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)0.17Not reported0.150.18Not reported
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)0.22Not reported0.021.00Not reported
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)0.08Not reported0.070.08Not reported
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)0.29Not reported0.020.50Not reported
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)0.08Not reported0.021.00Not reported
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)0.30Not reported0.050.50Not reported
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)0.03Not reported0.001.02Not reported
Dose Regimen A (DR-A) PTCL Expansion0.05Not reported0.020.48Not reported
Dose Regimen C (DR-C) PTCL Expansion0.05Not reported0.000.52Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        0.52
        value
        0.03
      2. group Id
        OG001
        lower Limit
        0.07
        upper Limit
        0.50
        value
        0.13
      3. group Id
        OG002
        lower Limit
        0.02
        upper Limit
        0.47
        value
        0.04
      4. group Id
        OG003
        lower Limit
        0.02
        upper Limit
        0.07
        value
        0.04
      5. group Id
        OG004
        lower Limit
        0.00
        upper Limit
        1.00
        value
        0.29
      6. group Id
        OG005
        lower Limit
        0.00
        upper Limit
        0.65
        value
        0.12
      7. group Id
        OG006
        lower Limit
        0.03
        upper Limit
        1.00
        value
        0.06
      8. group Id
        OG007
        lower Limit
        0.15
        upper Limit
        0.18
        value
        0.17
      9. group Id
        OG008
        lower Limit
        0.02
        upper Limit
        1.00
        value
        0.22
      10. group Id
        OG009
        lower Limit
        0.07
        upper Limit
        0.08
        value
        0.08
      11. group Id
        OG010
        lower Limit
        0.02
        upper Limit
        0.50
        value
        0.29
      12. group Id
        OG011
        lower Limit
        0.02
        upper Limit
        1.00
        value
        0.08
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      9
    7. group Id
      OG006
      value
      11
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      5
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      4
    12. group Id
      OG011
      value
      4
    units
    Participants
description
Time of Peak Plasma Concentration (Tmax)
dispersion Type
Full Range
groups
  1. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG000
    title
    Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
  2. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG001
    title
    Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
  3. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG002
    title
    Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
  4. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG003
    title
    Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation
  5. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG004
    title
    Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation
  6. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG005
    title
    Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation
  7. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG006
    title
    Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation
  8. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG007
    title
    Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
  9. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG008
    title
    Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
  10. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG009
    title
    Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
  11. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG010
    title
    Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
  12. description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    OG011
    title
    Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
param Type
MEDIAN
population Description
The Pharmacokinetic Analysis Population included all subjects who received at least one dose of ALRN-6924 with sufficient plasma sample data to assess PK parameters, and with no major protocol violations. Plasma samples for subjects in the Combination With Palbociclib Expansion arm were collected but will not be processed or analyzed due to a protocol-level decision for this expansion arm to discontinue pharmacokinetic data collection.
reporting Status
POSTED
time Frame
8 weeks
title
Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas
type
SECONDARY
unit Of Measure
hour

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Preserved source evidence · Not medical advice