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NCT03717415 · OUTCOME

Objective Response Rate (ORR) (Dose Expansion Phase)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)

What was measured

Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) 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: Expansion Phase mITT participants that were evaluable for this outcome measure.

Groups in this outcome

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 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC59
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC52
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC518
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC52
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC56
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC511

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC50Not reported0.028.3Not reported
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC50Not reported0.077.6Not reported
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC516.7Not reported4.737.7Not reported
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5100Not reported22.4100.0Not reported
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC50Not reported0.039.3Not reported
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC50Not reported0.023.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        28.3
        value
        0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        77.6
        value
        0
      3. group Id
        OG002
        lower Limit
        4.7
        upper Limit
        37.7
        value
        16.7
      4. group Id
        OG003
        lower Limit
        22.4
        upper Limit
        100.0
        value
        100
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        39.3
        value
        0
      6. group Id
        OG005
        lower Limit
        0.0
        upper Limit
        23.8
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      18
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      11
    units
    Participants
description
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) 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 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
    OG000
    title
    Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
  2. 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
    OG001
    title
    Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
  3. 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
    OG002
    title
    Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
  4. 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
    OG003
    title
    Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
  5. 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
    OG004
    title
    Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
  6. 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
    OG005
    title
    Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
param Type
NUMBER
population Description
Expansion Phase mITT participants that were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
title
Objective Response Rate (ORR) (Dose Expansion Phase)
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice