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NCT01362790 · OUTCOME

Count of Participants SS1P Cycles Received Following Onstudy

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Cycles 1-6, up to 180 days

What was measured

Here are the number of participants who had SS1P cycles during cycle 1-6.

Analysis population: No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

Groups in this outcome

Mesothelioma Pilot Phase 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 days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Mesothelioma Pilot Phase Regimen B

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase

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.

Phase 2 Pleural Mesothelioma Pilot Expansion Phase

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.

Phase 2 Pancreatic Adenocarcinoma Pilot Phase 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.

Phase 2 Lung Adenocarcinoma Pilot Expansion Phase 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.

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

Analysis denominator · Participants

GroupSource count
Mesothelioma Pilot Phase Regimen A11
Mesothelioma Pilot Phase Regimen B8
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase7
Phase 2 Pleural Mesothelioma Pilot Expansion Phase15
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A4
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A0

Reported measurements

SS1P 1 Cycle
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mesothelioma Pilot Phase Regimen A1Not reportedNot reportedNot reportedNot reported
Mesothelioma Pilot Phase Regimen B3Not reportedNot reportedNot reportedNot reported
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase0Not reportedNot reportedNot reportedNot reported
Phase 2 Pleural Mesothelioma Pilot Expansion Phase5Not reportedNot reportedNot reportedNot reported
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A2Not reportedNot reportedNot reportedNot reported
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A0Not reportedNot reportedNot reportedNot reported
SS1P 2 Cycles
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mesothelioma Pilot Phase Regimen A8Not reportedNot reportedNot reportedNot reported
Mesothelioma Pilot Phase Regimen B0Not reportedNot reportedNot reportedNot reported
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase4Not reportedNot reportedNot reportedNot reported
Phase 2 Pleural Mesothelioma Pilot Expansion Phase8Not reportedNot reportedNot reportedNot reported
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A1Not reportedNot reportedNot reportedNot reported
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A0Not reportedNot reportedNot reportedNot reported
SS1P 3 Cycles
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mesothelioma Pilot Phase Regimen A0Not reportedNot reportedNot reportedNot reported
Mesothelioma Pilot Phase Regimen B3Not reportedNot reportedNot reportedNot reported
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase0Not reportedNot reportedNot reportedNot reported
Phase 2 Pleural Mesothelioma Pilot Expansion Phase1Not reportedNot reportedNot reportedNot reported
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A1Not reportedNot reportedNot reportedNot reported
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A0Not reportedNot reportedNot reportedNot reported
SS1P 4 Cycles
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mesothelioma Pilot Phase Regimen A1Not reportedNot reportedNot reportedNot reported
Mesothelioma Pilot Phase Regimen B1Not reportedNot reportedNot reportedNot reported
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase3Not reportedNot reportedNot reportedNot reported
Phase 2 Pleural Mesothelioma Pilot Expansion Phase0Not reportedNot reportedNot reportedNot reported
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A0Not reportedNot reportedNot reportedNot reported
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A0Not reportedNot reportedNot reportedNot reported
SS1P 5 Cycles
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mesothelioma Pilot Phase Regimen A0Not reportedNot reportedNot reportedNot reported
Mesothelioma Pilot Phase Regimen B1Not reportedNot reportedNot reportedNot reported
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase0Not reportedNot reportedNot reportedNot reported
Phase 2 Pleural Mesothelioma Pilot Expansion Phase1Not reportedNot reportedNot reportedNot reported
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A0Not reportedNot reportedNot reportedNot reported
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A0Not reportedNot reportedNot reportedNot reported
SS1P 6 Cycles
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mesothelioma Pilot Phase Regimen A1Not reportedNot reportedNot reportedNot reported
Mesothelioma Pilot Phase Regimen B0Not reportedNot reportedNot reportedNot reported
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase0Not reportedNot reportedNot reportedNot reported
Phase 2 Pleural Mesothelioma Pilot Expansion Phase0Not reportedNot reportedNot reportedNot reported
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A0Not reportedNot reportedNot reportedNot reported
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
    title
    SS1P 1 Cycle
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    title
    SS1P 2 Cycles
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    title
    SS1P 3 Cycles
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    SS1P 4 Cycles
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    SS1P 5 Cycles
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    SS1P 6 Cycles
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      15
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      0
    units
    Participants
description
Here are the number of participants who had SS1P cycles during cycle 1-6.
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 days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    OG000
    title
    Mesothelioma Pilot Phase Regimen A
  2. description
    Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.
    id
    OG001
    title
    Mesothelioma Pilot Phase Regimen B
  3. 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.
    id
    OG002
    title
    Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
  4. 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.
    id
    OG003
    title
    Phase 2 Pleural Mesothelioma Pilot Expansion Phase
  5. 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.
    id
    OG004
    title
    Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
  6. 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.
    id
    OG005
    title
    Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
param Type
COUNT_OF_PARTICIPANTS
population Description
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
reporting Status
POSTED
time Frame
Cycles 1-6, up to 180 days
title
Count of Participants SS1P Cycles Received Following Onstudy
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice