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NCT01802632 · OUTCOME

Best Objective Response (BOR) for Dose Escalation Population

AZD9291 First Time In Patients Ascending Dose Study · Source last updated 2026-04-20

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

Measure
NUMBER
Unit
% of participants
Interval / dispersion
Not reported
Time frame
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)

What was measured

Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.

Analysis population: All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.

Groups in this outcome

Dose Escalation

Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.

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 Escalation31

Reported measurements

Partial Response
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation58.1Not reported54.168.9Not reported
Stable disease
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation19.4Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation16.1Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation6.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.1
        upper Limit
        68.9
        value
        58.1
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        19.4
    title
    Stable disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16.1
    title
    Progressive disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6.5
    title
    Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.
groups
  1. description
    Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
    id
    OG000
    title
    Dose Escalation
param Type
NUMBER
population Description
All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.
reporting Status
POSTED
time Frame
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)
title
Best Objective Response (BOR) for Dose Escalation Population
type
PRIMARY
unit Of Measure
% of participants

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

Preserved source evidence · Not medical advice