Participant flow

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer · Source last updated 2021-08-12

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

groups

1. description

   Participants received sacituzumab govitecan-hziy (SG) 8 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.

   id

   FG000

   title

   Sacituzumab Govitecan-hziy (SG) 8 mg/kg

2. description

   Participants received sacituzumab govitecan-hziy 10 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.

   id

   FG001

   title

   SG 10 mg/kg

3. description

   Participants received sacituzumab govitecan-hziy 12 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.

   id

   FG002

   title

   SG 12 mg/kg

4. description

   Participants received sacituzumab govitecan-hziy 18 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.

   id

   FG003

   title

   SG 18 mg/kg

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         83

      2. group Id

         FG001

         num Subjects

         420

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         81

      2. group Id

         FG001

         num Subjects

         402

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         3

      type

      Enrolled and Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         81

      2. group Id

         FG001

         num Subjects

         400

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         3

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Tumor types included in the study were as follows: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).

recruitment Details

Participants were enrolled at study sites in the United States. The first participant was screened on 17 December 2012. The last study visit occurred on 13 August 2020. Outcome Measures were assessed up to the data cutoff date of 01 March 2019. Following the data cutoff date, the participants either stayed on the study and were followed for safety data collection or rolled into another Gilead-sponsored study. Therefore, only safety data was collected after the data cutoff date.

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Preserved source evidence · Not medical advice