Baseline characteristics

Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma · Source last updated 2019-03-11

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

      24

   units

   Participants

groups

1. description

   Single arm consists of temsirolimus (Torisel) plus liposomal doxorubicin (Doxil). Temsirolimus is administered IV in sequentially escalating cohorts at doses between 15 and 50 mg/M2 (body surface area), once weekly. Liposomal doxorubicin is administered IV at 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Temsirolimus may continue beyond 2 years. temsirolimus plus liposomal doxorubicin: Patients will be treated with temsirolimus (Torisel) temsirolimus weekly by iv and with liposomal doxorubicin (Doxil) (standard dose) by iv once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until maximally tolerated dose (MTD) is reached. Once MTD (standard dose) is achieved, dosing will be with standard doses for each drug, but dosing will be modified based on toxicity.

   id

   BG000

   title

   Temsirolimus Plus Liposomal Doxorubicin

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            5

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            17

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            2

         title

         >=65 years

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Age, Categorical

   unit Of Measure

   Participants

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            9

            upper Limit

            70

            value

            39.5

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Age, Continuous

   unit Of Measure

   years

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            14

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            10

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            24

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

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Preserved source evidence · Not medical advice