Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01609556 · OUTCOME

Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors · Source last updated 2021-02-17

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
95% Confidence Interval
Time frame
From first dose of study drug until first BOR of CR or PR (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)

What was measured

ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.

Analysis population: Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.

Groups in this outcome

Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)

Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)

Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)

Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)

Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

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

Analysis denominator · Participants

GroupSource count
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)43
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)24
Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)113
Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)24

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)5Not reported0.615.8Not reported
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)13Not reported2.732.4Not reported
Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)30Not reported21.839.4Not reported
Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)8Not reported1.027.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        15.8
        value
        5
      2. group Id
        OG001
        lower Limit
        2.7
        upper Limit
        32.4
        value
        13
      3. group Id
        OG002
        lower Limit
        21.8
        upper Limit
        39.4
        value
        30
      4. group Id
        OG003
        lower Limit
        1.0
        upper Limit
        27.0
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      24
    3. group Id
      OG002
      value
      113
    4. group Id
      OG003
      value
      24
    units
    Participants
description
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG000
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
  2. description
    Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG001
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
  3. description
    Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG002
    title
    Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)
  4. description
    Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG003
    title
    Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)
param Type
NUMBER
population Description
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.
reporting Status
POSTED
time Frame
From first dose of study drug until first BOR of CR or PR (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
title
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice