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NCT03717415 · OUTCOME

Duration of Response (DOR)

A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors · Source last updated 2024-12-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
Time from PR or CR to PD or Death due to Any Cause (up to 1.53 years)

What was measured

Time from first partial response (PR) or complete response (CR) to disease progression (PD) or death due to any cause. Evaluation of radiographic disease assessment per Response Evaluation Criteria in Solid Tumor (RECIST v1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.

Analysis population: mITT participants that had CR or PR and were evaluable for this outcome measure.

Groups in this outcome

Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5

Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5

Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6

Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.

Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5

Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5

Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5

Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5

Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5

Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5

Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

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 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC50
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC50
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC60
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC50
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC50
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC53
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC52
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC50
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC50

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC511.8Not reportedNANAThe 90% Confidence Interval (CI) was not estimable due to insufficient number of events.
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC513.5Not reported8.6NAThe 90% CI was not estimable due to insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The 90% Confidence Interval (CI) was not estimable due to insufficient number of events.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        11.8
      2. comment
        The 90% CI was not estimable due to insufficient number of events.
        group Id
        OG006
        lower Limit
        8.6
        upper Limit
        NA
        value
        13.5
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      2
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    units
    Participants
description
Time from first partial response (PR) or complete response (CR) to disease progression (PD) or death due to any cause. Evaluation of radiographic disease assessment per Response Evaluation Criteria in Solid Tumor (RECIST v1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
dispersion Type
90% Confidence Interval
groups
  1. description
    Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    OG000
    title
    Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
  2. description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    OG001
    title
    Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
  3. description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
    id
    OG002
    title
    Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
  4. description
    Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    OG003
    title
    Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
  5. description
    Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    OG004
    title
    Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
  6. description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    OG005
    title
    Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
  7. description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    OG006
    title
    Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
  8. description
    Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    OG007
    title
    Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
  9. description
    Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    OG008
    title
    Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
param Type
MEDIAN
population Description
mITT participants that had CR or PR and were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Time from PR or CR to PD or Death due to Any Cause (up to 1.53 years)
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice