Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03190174 · OUTCOME

Maximum Tolerated Dose of ABI-009

Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers · Source last updated 2025-02-17

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

Measure
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
Week 6

What was measured

The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced dose-limiting toxicity (DLT), with the next higher dose level having at least two patients who experienced DLT.

Analysis population: Intention-to-treat population (all participant assigned to the Phase I dose escalation part of the study).

Groups in this outcome

Dose Escalation Phase 1

The study will employ the standard "cohort of three" design. Patients receive ABI-009 in level I dose - 56 mg/m\^2, in level II dose - 75 mg/m\^2, and level III dose - 100 mg/m\^2, each with defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.

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 Escalation Phase 19

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Phase 1100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced dose-limiting toxicity (DLT), with the next higher dose level having at least two patients who experienced DLT.
groups
  1. description
    The study will employ the standard "cohort of three" design. Patients receive ABI-009 in level I dose - 56 mg/m\^2, in level II dose - 75 mg/m\^2, and level III dose - 100 mg/m\^2, each with defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.
    id
    OG000
    title
    Dose Escalation Phase 1
param Type
NUMBER
population Description
Intention-to-treat population (all participant assigned to the Phase I dose escalation part of the study).
reporting Status
POSTED
time Frame
Week 6
title
Maximum Tolerated Dose of ABI-009
type
PRIMARY
unit Of Measure
mg/m^2

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

Preserved source evidence · Not medical advice