Participant flow

Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma · Source last updated 2021-09-27

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

groups

1. description

   Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO

   id

   FG000

   title

   Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride

2. description

   Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO Placebo Administration: Given PO

   id

   FG001

   title

   Gemcitabine Hydrochloride Plus Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         1

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol-defined delay > 3 weeks

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         25

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         14

      comment

      Participants who progress, unblinded, and found treated with gemcitibine+placebo arm are eligible to crossover into pazopanib open-label treatment phase

      type

      Crossover to Open-label Pazopanib

   3. achievements

      1. comment

         Participants remain on treatment until time of progression and through the AE assessment period

         group Id

         FG000

         num Subjects

         15

      2. comment

         Participants remain on treatment until time of progression

         group Id

         FG001

         num Subjects

         23

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Double-blinded randomization (1:1) was stratified by subtypes of sarcoma (liposarcoma vs. all other eligible soft tissue sarcoma subtypes). Patients were randomized to either experimental arm or placebo arm prior to starting treatment. Those who discontinued treatment on the placebo arm due to disease progression were eligible for treatment with open-label pazopanib (unblinded, cross-over treatment); those who developed disease progression on the Experimental arm (pazopanib arm) were not.

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Preserved source evidence · Not medical advice