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NCT01362790 · OUTCOME

Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01

SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma · Source last updated 2019-06-06

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

Measure
NUMBER
Unit
mcg/kg/dose
Interval / dispersion
Not reported
Time frame
Days 1, 3, and 5 of a 21 day cycle

What was measured

Should any 2 patients within the first 3 to 6 patients experience treatment limiting toxicity requiring cessation of treatment prior to the conclusion of the first cycle, the maximum tolerated dose will have been exceeded and patients will be enrolled to the next lower dose.

Groups in this outcome

Meso., Peritoneal, Pleural & Pancreatic Regimen A

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles. During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.

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

Analysis denominator · Participants

GroupSource count
Meso., Peritoneal, Pleural & Pancreatic Regimen A8

Reported measurements

Source class 1
Values in mcg/kg/dose · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Meso., Peritoneal, Pleural & Pancreatic Regimen A25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Should any 2 patients within the first 3 to 6 patients experience treatment limiting toxicity requiring cessation of treatment prior to the conclusion of the first cycle, the maximum tolerated dose will have been exceeded and patients will be enrolled to the next lower dose.
groups
  1. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles. During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.
    id
    OG000
    title
    Meso., Peritoneal, Pleural & Pancreatic Regimen A
param Type
NUMBER
reporting Status
POSTED
time Frame
Days 1, 3, and 5 of a 21 day cycle
title
Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01
type
PRIMARY
unit Of Measure
mcg/kg/dose

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

Preserved source evidence · Not medical advice