Participant flow

Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer · Source last updated 2023-07-20

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

groups

1. description

   platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist. (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). (AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy. AT-101: Patients will receive AT-101 40 mg orally two times a day. Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg

   id

   FG000

   title

   Platinum/Docetaxal + AT-101

2. description

   (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg

   id

   FG001

   title

   Active Comparator Arm

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         18

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         18

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

one subject was enrolled; however, disease progression was discovered before active treatment and therefore the patient never was treated with study drug

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Preserved source evidence · Not medical advice