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NCT02420795 · OUTCOME

Number of Participants With Overall Response Rate (Phase 1 and 2)

Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2022-04-04

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 63 days (first 3 courses)

What was measured

Defined as either progressive disease or stable disease observed assessed by the Revised International Workshop Standardization Response Criteria for non-Hodgkin lymphoma.

Analysis population: 1 patient passed away prior to restaging in Phase 2 Arm B

Groups in this outcome

ONC201 125 mg

Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ONC201 250 mg

Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ONC201 625 mg

Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
ONC201 125 mg4
ONC201 250 mg2
ONC201 625 mg5

Reported measurements

Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ONC201 125 mg3Not reportedNot reportedNot reportedNot reported
ONC201 250 mg1Not reportedNot reportedNot reportedNot reported
ONC201 625 mg3Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ONC201 125 mg1Not reportedNot reportedNot reportedNot reported
ONC201 250 mg1Not reportedNot reportedNot reportedNot reported
ONC201 625 mg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
    title
    Progressive Disease
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Stable Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Defined as either progressive disease or stable disease observed assessed by the Revised International Workshop Standardization Response Criteria for non-Hodgkin lymphoma.
groups
  1. description
    Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    ONC201 125 mg
  2. description
    Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    ONC201 250 mg
  3. description
    Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG002
    title
    ONC201 625 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
1 patient passed away prior to restaging in Phase 2 Arm B
reporting Status
POSTED
time Frame
Up to 63 days (first 3 courses)
title
Number of Participants With Overall Response Rate (Phase 1 and 2)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice