Baseline characteristics

Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II) · Source last updated 2021-07-20

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

denoms

1. counts

   1. group Id

      BG000

      value

      40

   2. group Id

      BG001

      value

      23

   3. group Id

      BG002

      value

      6

   4. group Id

      BG003

      value

      69

   units

   Participants

groups

1. description

   pemetrexed, cisplatin and CBP501 pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP. Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL. Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.

   id

   BG000

   title

   Pemetrexed, Cisplatin, and CBP501: Phase 2

2. description

   pemetrexed and cisplatin pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL. Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.

   id

   BG001

   title

   Pemetrexed and Cisplatin: Phase 2

3. description

   DL1: CBP501 16mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2

   id

   BG002

   title

   Pemetrexed, Cisplatin, and CBP501: Phase 1

4. description

   Total of all reporting groups

   id

   BG003

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            10.03

            value

            63

         2. group Id

            BG001

            spread

            12.10

            value

            66.3

         3. group Id

            BG002

            spread

            13.61

            value

            62.8

         4. group Id

            BG003

            spread

            10.86

            value

            64.2

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            8

         2. group Id

            BG001

            value

            3

         3. group Id

            BG002

            value

            1

         4. group Id

            BG003

            value

            12

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            32

         2. group Id

            BG001

            value

            20

         3. group Id

            BG002

            value

            5

         4. group Id

            BG003

            value

            57

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

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Preserved source evidence · Not medical advice