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NCT02464228 · OUTCOME

Progression-free Survival (PFS)

Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy · Source last updated 2024-06-26

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
Up to approximately 3 years

What was measured

PFS was defined as the time (in months) from first dose (Cycle 1 Day 1) to either first observation of progressive disease (PD) or occurrence of death due to any cause within 126 days (approximately 2 time-intervals for tumor assessments) of either first administration of tipifarnib or the last tumor assessment. Observation of PD could have been by either documented radiographic progression (i.e., scan results) or documentation of symptomatic or clinical progression agreed upon and documented by investigators. In subjects without a progression date or with a death date more than 126 days after the first administration of study drugs or the last tumor assessment, the PFS time was censored on the date of last tumor assessment or date of first administration of study tipifarnib. The duration of the PFS was analyzed using the Kaplan-Meier (KM) method. 95% CIs were calculated using Hall-Wellner Method.

Analysis population: The FAS Population excluding subjects for the following reasons: no Baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug.

Groups in this outcome

Cohort AITL

Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.

Cohort PTCL-NOS

Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.

Cohort PTCL-NOS, CXCL12+

Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.

Cohort Other

Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.

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

Analysis denominator · Participants

GroupSource count
Cohort AITL32
Cohort PTCL-NOS14
Cohort PTCL-NOS, CXCL12+10
Cohort Other2

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort AITL3.6Not reported1.98.3Not reported
Cohort PTCL-NOS2.1Not reported1.44.0Not reported
Cohort PTCL-NOS, CXCL12+5.3Not reported1.811.1Not reported
Cohort Other1.4Not reported1.11.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        8.3
        value
        3.6
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        4.0
        value
        2.1
      3. group Id
        OG002
        lower Limit
        1.8
        upper Limit
        11.1
        value
        5.3
      4. group Id
        OG003
        lower Limit
        1.1
        upper Limit
        1.6
        value
        1.4
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      2
    units
    Participants
description
PFS was defined as the time (in months) from first dose (Cycle 1 Day 1) to either first observation of progressive disease (PD) or occurrence of death due to any cause within 126 days (approximately 2 time-intervals for tumor assessments) of either first administration of tipifarnib or the last tumor assessment. Observation of PD could have been by either documented radiographic progression (i.e., scan results) or documentation of symptomatic or clinical progression agreed upon and documented by investigators. In subjects without a progression date or with a death date more than 126 days after the first administration of study drugs or the last tumor assessment, the PFS time was censored on the date of last tumor assessment or date of first administration of study tipifarnib. The duration of the PFS was analyzed using the Kaplan-Meier (KM) method. 95% CIs were calculated using Hall-Wellner Method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    OG000
    title
    Cohort AITL
  2. description
    Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    OG001
    title
    Cohort PTCL-NOS
  3. description
    Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    OG002
    title
    Cohort PTCL-NOS, CXCL12+
  4. description
    Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    OG003
    title
    Cohort Other
param Type
MEDIAN
population Description
The FAS Population excluding subjects for the following reasons: no Baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice