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NCT01962103 · OUTCOME

Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors · Source last updated 2019-12-27

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
DLT assessment period: For participants > 10 kg: the first 28-day cycle including Cycle 2 Day 1 predose evaluations; for participants ≤ 10 kg: the first two 28-day cycles including Cycle 3 Day 1 predose evaluations

What was measured

A DLT was defined as investigational product (IP)-related adverse events occurring during the DLT assessment period that led to treatment discontinuation or met one of the following criteria: - Common Terminology Criteria for Adverse Events (CTCAE) Grade (Gr) 3 or 4 nonhematologic toxicity (excluding transient transaminitis) - CTCAE Gr 3 or 4 nausea or vomiting that persisted \> 5 days despite maximal anti-emetic treatment - CTCAE Gr 4 thrombocytopenia or anemia that persisted \> 7 days or required transfusion \> 7 days - CTCAE Gr 3 thrombocytopenia with bleeding - CTCAE Gr 4 uncomplicated neutropenia lasting \> 7 days - Febrile neutropenia with confirmed bacterial infection - CTCAE Gr 3 hematologic toxicity requiring treatment (tx) delay \> 21 days. Use of "..." in the table rows signifies the continuation of row title per the above list.

Analysis population: Dose Determining Set (DDS): all Phase 1 participants who received all 3 weekly doses of nab-paclitaxel at the cohort planned dose during Cycle 1 and had adequate safety assessments during the DLT assessment period or experienced a DLT. The DDS did not include participants who were enrolled at each dose once the dose had been determined to be safe.

Groups in this outcome

Phase 1: Nab-Paclitaxel 120 mg/m^2

nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).

Phase 1: Nab-Paclitaxel 150 mg/m^2

nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

Phase 1: Nab-Paclitaxel 180 mg/m^2

nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

Phase 1: Nab-Paclitaxel 210 mg/m^2

nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

Phase 1: Nab-Paclitaxel 240 mg/m^2

nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

Phase 1: Nab-Paclitaxel 270 mg/m^2

nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

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

Analysis denominator · Participants

GroupSource count
Phase 1: Nab-Paclitaxel 120 mg/m^26
Phase 1: Nab-Paclitaxel 150 mg/m^26
Phase 1: Nab-Paclitaxel 180 mg/m^26
Phase 1: Nab-Paclitaxel 210 mg/m^26
Phase 1: Nab-Paclitaxel 240 mg/m^26
Phase 1: Nab-Paclitaxel 270 mg/m^27

Reported measurements

At least 1 DLT
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^21Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^21Not reportedNot reportedNot reportedNot reported
Gr 3/4 Nonhematologic Toxicity...
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^21Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^20Not reportedNot reportedNot reportedNot reported
Gr 3/4 Nausea or Vomiting Persisting >5 days...
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^20Not reportedNot reportedNot reportedNot reported
Gr 4 Thrombocytopenia/Anemia Persisting >7 days...
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^20Not reportedNot reportedNot reportedNot reported
Gr 3 Thrombocytopenia with Bleeding
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^20Not reportedNot reportedNot reportedNot reported
Gr 4 Uncomplicated Neutropenia Lasting >7 days
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^21Not reportedNot reportedNot reportedNot reported
Febrile Neutropenia+Confirmed Bacterial Infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^20Not reportedNot reportedNot reportedNot reported
Gr3 Hematologic Toxicity Requiring Tx Delay...
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      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
        1
    title
    At least 1 DLT
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      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
    title
    Gr 3/4 Nonhematologic Toxicity...
  3. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Gr 3/4 Nausea or Vomiting Persisting >5 days...
  4. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Gr 4 Thrombocytopenia/Anemia Persisting >7 days...
  5. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Gr 3 Thrombocytopenia with Bleeding
  6. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
    title
    Gr 4 Uncomplicated Neutropenia Lasting >7 days
  7. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Febrile Neutropenia+Confirmed Bacterial Infection
  8. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Gr3 Hematologic Toxicity Requiring Tx Delay...
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      7
    units
    Participants
description
A DLT was defined as investigational product (IP)-related adverse events occurring during the DLT assessment period that led to treatment discontinuation or met one of the following criteria: - Common Terminology Criteria for Adverse Events (CTCAE) Grade (Gr) 3 or 4 nonhematologic toxicity (excluding transient transaminitis) - CTCAE Gr 3 or 4 nausea or vomiting that persisted \> 5 days despite maximal anti-emetic treatment - CTCAE Gr 4 thrombocytopenia or anemia that persisted \> 7 days or required transfusion \> 7 days - CTCAE Gr 3 thrombocytopenia with bleeding - CTCAE Gr 4 uncomplicated neutropenia lasting \> 7 days - Febrile neutropenia with confirmed bacterial infection - CTCAE Gr 3 hematologic toxicity requiring treatment (tx) delay \> 21 days. Use of "..." in the table rows signifies the continuation of row title per the above list.
groups
  1. description
    nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
    id
    OG000
    title
    Phase 1: Nab-Paclitaxel 120 mg/m^2
  2. description
    nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG001
    title
    Phase 1: Nab-Paclitaxel 150 mg/m^2
  3. description
    nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG002
    title
    Phase 1: Nab-Paclitaxel 180 mg/m^2
  4. description
    nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG003
    title
    Phase 1: Nab-Paclitaxel 210 mg/m^2
  5. description
    nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG004
    title
    Phase 1: Nab-Paclitaxel 240 mg/m^2
  6. description
    nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG005
    title
    Phase 1: Nab-Paclitaxel 270 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
Dose Determining Set (DDS): all Phase 1 participants who received all 3 weekly doses of nab-paclitaxel at the cohort planned dose during Cycle 1 and had adequate safety assessments during the DLT assessment period or experienced a DLT. The DDS did not include participants who were enrolled at each dose once the dose had been determined to be safe.
reporting Status
POSTED
time Frame
DLT assessment period: For participants > 10 kg: the first 28-day cycle including Cycle 2 Day 1 predose evaluations; for participants ≤ 10 kg: the first two 28-day cycles including Cycle 3 Day 1 predose evaluations
title
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice