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NCT01672736 · OUTCOME

Maximum Tolerated Dose of the Combination of ASP7487 (OSI-906) With Velcade and Dexamethasone

A Trial of ASP7487 (OSI-906) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma · Source last updated 2018-09-13

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

Measure
NUMBER
Unit
milligrams
Interval / dispersion
Not reported
Time frame
45 months

What was measured

* Phase 1: To determine the maximum tolerated dose (MTD) of ASP7487 (OSI-906) administered in combination with the recommended dose and schedule of bortezomib and dexamethasone; * Phase 2: To evaluate the antitumor activity of ASP7487 (OSI-906) in combination with bortezomib and dexamethasone at the MTD established from the Phase 1 component.

Groups in this outcome

ASP7487, Velcade, Dexamethasone

ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration

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

Analysis denominator · Participants

GroupSource count
ASP7487, Velcade, Dexamethasone19

Reported measurements

Linsitinib starting dose in milligrams
Values in milligrams · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ASP7487, Velcade, Dexamethasone75Not reportedNot reportedNot reportedNot reported
Linsitinib maximum dose in milligrams
Values in milligrams · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ASP7487, Velcade, Dexamethasone150Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        75
    title
    Linsitinib starting dose in milligrams
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        150
    title
    Linsitinib maximum dose in milligrams
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
* Phase 1: To determine the maximum tolerated dose (MTD) of ASP7487 (OSI-906) administered in combination with the recommended dose and schedule of bortezomib and dexamethasone; * Phase 2: To evaluate the antitumor activity of ASP7487 (OSI-906) in combination with bortezomib and dexamethasone at the MTD established from the Phase 1 component.
groups
  1. description
    ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration
    id
    OG000
    title
    ASP7487, Velcade, Dexamethasone
param Type
NUMBER
reporting Status
POSTED
time Frame
45 months
title
Maximum Tolerated Dose of the Combination of ASP7487 (OSI-906) With Velcade and Dexamethasone
type
PRIMARY
unit Of Measure
milligrams

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

Preserved source evidence · Not medical advice