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NCT00101413 · OUTCOME

Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)

BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC) · Source last updated 2013-10-30

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.

What was measured

CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- \>=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- \>=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- \>clinically meaningful cancer-related deterioration as judged by the investigator.

Analysis population: The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.

Groups in this outcome

Sorafenib

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles

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

Analysis denominator · Participants

GroupSource count
Sorafenib51

Reported measurements

Complete response + Partial response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib0.0Not reportedNot reportedNot reportedNot reported
Complete response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib0.0Not reportedNot reportedNot reportedNot reported
Partial response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib0.0Not reportedNot reportedNot reportedNot reported
Stable disease
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib58.8Not reportedNot reportedNot reportedNot reported
Progressive disease measurement proven
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib23.5Not reportedNot reportedNot reportedNot reported
Progression by clinical judgement
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib11.8Not reportedNot reportedNot reportedNot reported
Not evaluated
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib5.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
    title
    Complete response + Partial response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
    title
    Complete response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
    title
    Partial response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        58.8
    title
    Stable disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        23.5
    title
    Progressive disease measurement proven
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        11.8
    title
    Progression by clinical judgement
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5.9
    title
    Not evaluated
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- \>=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- \>=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- \>clinically meaningful cancer-related deterioration as judged by the investigator.
groups
  1. description
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    id
    OG000
    title
    Sorafenib
param Type
NUMBER
population Description
The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.
reporting Status
POSTED
time Frame
First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.
title
Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice