NCT02487095 · OUTCOME

Phase I: Number of Participants With a Change in H2AX Phosphorylation (ƴH2AX) Levels in Peripheral Blood Mononuclear Cells (PBMCs) From Baseline (Day 1 Pre-Treatment)

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Day 1 Pre-Treatment, Post treatment on day 2, and Post treatment on day 3

What was measured

PBMCs were obtained from participants to determine a change in H2AX phosphorylation (named ƴH2AX) in peripheral blood mononuclear cells (PBMCs) when compared to baseline (day 1 pre-treatment). ƴH2AX was detected by immunochemistry (microscopy) by using an antibody specific against ƴH2AX that, in turn, was detected by a secondary antibody conjugated to a fluorescent probe. Changes in ƴH2AX levels in PBMCs is defined as changes in numbers of ƴH2AX foci per cells.

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 DL2 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

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	6
Phase I DL2 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	6

Reported measurements

Post treatment on day 2

Values in Participants · Interval/dispersion: Not reported
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	5	Not reported	Not reported	Not reported	Not reported
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5	2	Not reported	Not reported	Not reported	Not reported
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5	3	Not reported	Not reported	Not reported	Not reported
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5	3	Not reported	Not reported	Not reported	Not reported

Post treatment on day 3

Values in Participants · Interval/dispersion: Not reported
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	6	Not reported	Not reported	Not reported	Not reported
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5	6	Not reported	Not reported	Not reported	Not reported
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5	2	Not reported	Not reported	Not reported	Not reported
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
3
title
Post treatment on day 2
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
2
group Id
OG003
value
3
title
Post treatment on day 3

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
3
group Id
OG003
value
6
units
Participants

description

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 DL2 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

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Day 1 Pre-Treatment, Post treatment on day 2, and Post treatment on day 3

title

Phase I: Number of Participants With a Change in H2AX Phosphorylation (ƴH2AX) Levels in Peripheral Blood Mononuclear Cells (PBMCs) From Baseline (Day 1 Pre-Treatment)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice