NCT02487095 · OUTCOME

Phase I and Phase II: Duration of Response (DOR)

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 5.25 months.

What was measured

DOR is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented in response to the combination in both platinum sensitive and refractory patients. CR is disappearance of all non-target lesions and normalization of tumor marker level. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Analysis population: 1/26 participants were not evaluable in the Phase II DL4 SCLC group. 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). Only 1 participant was evaluable in Phase 1 DL1 and Phase 1 DL4.

Groups in this outcome

Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5

Phase I Dose Level (DL) 1 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 5

Phase I DL 2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5

Phase I Dose Level (DL) 2 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5

Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5

Phase I Dose Level (DL) 3 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5

Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5

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

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

Group	Source count
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5	1
Phase I DL 2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5	6
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5	3
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5	1
Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV	25
Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV	15

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5	NA	Not reported	66.5	NA	Median and Lower end of confidence interval is not estimable for 1 participant.
Phase I DL 2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5	NA	Not reported	NA	NA	No partial response.
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5	NA	Not reported	NA	NA	No partial response.
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5	NA	Not reported	53.4	NA	Median and Lower end of confidence interval is not estimable for 1 participant.
Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV	4.9	Not reported	0.6	6.9	Not reported
Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV	5.6	Not reported	4.4	6.9	Not reported

Complete source fields

classes

categories
measurements
comment
Median and Lower end of confidence interval is not estimable for 1 participant.
group Id
OG000
lower Limit
66.5
upper Limit
NA
value
NA
comment
No partial response.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
comment
No partial response.
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA
comment
Median and Lower end of confidence interval is not estimable for 1 participant.
group Id
OG003
lower Limit
53.4
upper Limit
NA
value
NA
group Id
OG004
lower Limit
0.6
upper Limit
6.9
value
4.9
group Id
OG005
lower Limit
4.4
upper Limit
6.9
value
5.6

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
6
group Id
OG002
value
3
group Id
OG003
value
1
group Id
OG004
value
25
group Id
OG005
value
15
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Phase I Dose Level (DL) 1 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 5
id
OG000
title
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5
description
Phase I Dose Level (DL) 2 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5
id
OG001
title
Phase I DL 2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5
description
Phase I Dose Level (DL) 3 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5
id
OG002
title
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5
description
Phase I Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5
id
OG003
title
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5
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
OG004
title
Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV
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
OG005
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

1/26 participants were not evaluable in the Phase II DL4 SCLC group. 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). Only 1 participant was evaluable in Phase 1 DL1 and Phase 1 DL4.

reporting Status

POSTED

time Frame

At disease progression, an average of 5.25 months.

title

Phase I and Phase II: Duration of Response (DOR)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice