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NCT00112736 · OUTCOME

Maximum Tolerated Dose (Phase I)

Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma · Source last updated 2015-06-15

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
based on first 4 weeks of treatment - cycle 1

What was measured

Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed. 3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg

Analysis population: Per protocol -

Groups in this outcome

Phase I - Dose Escalation

Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at (dose escalation or dose de-escalation). Every 28 days until disease progression or unacceptable toxicity. Dose levels: cohort 1 - 50mg - 3pts cohort 2 - 25mg -6pt cohort 3 - 15mg - 12pts

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 I - Dose Escalation21

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - Dose Escalation15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed. 3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg
groups
  1. description
    Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at (dose escalation or dose de-escalation). Every 28 days until disease progression or unacceptable toxicity. Dose levels: cohort 1 - 50mg - 3pts cohort 2 - 25mg -6pt cohort 3 - 15mg - 12pts
    id
    OG000
    title
    Phase I - Dose Escalation
param Type
NUMBER
population Description
Per protocol -
reporting Status
POSTED
time Frame
based on first 4 weeks of treatment - cycle 1
title
Maximum Tolerated Dose (Phase I)
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice