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NCT02064387 · OUTCOME

ORR-Part 2 (NHL)

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

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
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 7.2 months)

What was measured

Overall Response Rate in NHL population was determined by the investigator according to Revised Response Criteria for Malignant Lymphoma. ORR was calculated as the number of participants with confirmed complete remission (CR) or partial remission (PR). Complete remission was defined as disappearance of all evidence of disease and partial remission was defined as regression of measurable disease and no new sites.

Analysis population: Part 2 NHL Population

Groups in this outcome

Part 2: GSK2857916 3.40 mg/kg (NHL)

Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).

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

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Overall Response Rate in NHL population was determined by the investigator according to Revised Response Criteria for Malignant Lymphoma. ORR was calculated as the number of participants with confirmed complete remission (CR) or partial remission (PR). Complete remission was defined as disappearance of all evidence of disease and partial remission was defined as regression of measurable disease and no new sites.
groups
  1. description
    Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).
    id
    OG000
    title
    Part 2: GSK2857916 3.40 mg/kg (NHL)
param Type
COUNT_OF_PARTICIPANTS
population Description
Part 2 NHL Population
reporting Status
POSTED
time Frame
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 7.2 months)
title
ORR-Part 2 (NHL)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice