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NCT02487095 · OUTCOME

Phase II: Progression-free Survival (PFS)

Trial of Topotecan With VX-970 (M6620), an ATR Kinase Inhibitor, in Small Cell Cancers and Extrapulmonary Small Cell Cancers · Source last updated 2025-04-13

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
At disease progression, an average of 3.28 months.

What was measured

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Analysis population: The Phase II, DL4 Arm/Group is split into two groups for this outcome measure because the distinction is relevant for the phase II, DL4 since extrapulmonary small cell cancers (EPSCC) was an exploratory cohort of the phase II DL4 (added with an amendment).1/26 participants was not evaluable for response in the Phase II DL4 SCLC group.

Groups in this outcome

Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV

Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose.

Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV

Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose.

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 II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV25
Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV15

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV4.6Not reported2.37.2Not reported
Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV2.2Not reported0.92.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.3
        upper Limit
        7.2
        value
        4.6
      2. group Id
        OG001
        lower Limit
        0.9
        upper Limit
        2.9
        value
        2.2
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      15
    units
    Participants
description
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
dispersion Type
95% Confidence Interval
groups
  1. description
    Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose.
    id
    OG000
    title
    Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV
  2. description
    Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose.
    id
    OG001
    title
    Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV
param Type
MEDIAN
population Description
The Phase II, DL4 Arm/Group is split into two groups for this outcome measure because the distinction is relevant for the phase II, DL4 since extrapulmonary small cell cancers (EPSCC) was an exploratory cohort of the phase II DL4 (added with an amendment).1/26 participants was not evaluable for response in the Phase II DL4 SCLC group.
reporting Status
POSTED
time Frame
At disease progression, an average of 3.28 months.
title
Phase II: Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice