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NCT03717415 · OUTCOME

Objective Response Rate (ORR) (Dose Escalation 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: Escalation Phase mITT participants that 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.

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 AUC53
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC512
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC65

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC50Not reported0.063.2Not reported
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC50Not reported0.022.1Not reported
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC60Not reported0.045.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        63.2
        value
        0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        22.1
        value
        0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        45.1
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      5
    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 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
param Type
NUMBER
population Description
Escalation 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 Escalation Phase)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice