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NCT02567422 · OUTCOME

Number of Participants Experiencing a Dose Limiting Toxicities

Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer · Source last updated 2026-07-31

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
Up to 3 weeks after completion of radiation therapy

What was measured

Dose limiting toxicities are protocol-specific adverse events considered at least possibly related to the study intervention. Graded according to NCI CTCAE v5.

Analysis population: Dose limiting toxicities (DLTs) are only evaluated in participants during dose escalation (i.e. Dose Levels 1, 2, and 3). Participants not completing the treatment for reasons other than an adverse event (i.e. withdrawal or non-compliance with treatment) are excluded from the analysis. DLTs were not evaluated for participants enrolled in Dose Expansion.

Groups in this outcome

Dose Level 1

Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.

Dose Level 2

Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.

Dose Level 3

Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.

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 Level 19
Dose Level 26
Dose Level 39

Reported measurements

Experiencing a DLT
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 12Not reportedNot reportedNot reportedNot reported
Dose Level 21Not reportedNot reportedNot reportedNot reported
Dose Level 32Not reportedNot reportedNot reportedNot reported
Did not experience a DLT
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 17Not reportedNot reportedNot reportedNot reported
Dose Level 25Not reportedNot reportedNot reportedNot reported
Dose Level 37Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Experiencing a DLT
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        7
    title
    Did not experience a DLT
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      9
    units
    Participants
description
Dose limiting toxicities are protocol-specific adverse events considered at least possibly related to the study intervention. Graded according to NCI CTCAE v5.
groups
  1. description
    Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
    id
    OG000
    title
    Dose Level 1
  2. description
    Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
    id
    OG001
    title
    Dose Level 2
  3. description
    Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
    id
    OG002
    title
    Dose Level 3
param Type
COUNT_OF_PARTICIPANTS
population Description
Dose limiting toxicities (DLTs) are only evaluated in participants during dose escalation (i.e. Dose Levels 1, 2, and 3). Participants not completing the treatment for reasons other than an adverse event (i.e. withdrawal or non-compliance with treatment) are excluded from the analysis. DLTs were not evaluated for participants enrolled in Dose Expansion.
reporting Status
POSTED
time Frame
Up to 3 weeks after completion of radiation therapy
title
Number of Participants Experiencing a Dose Limiting Toxicities
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice