Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania) › P2B-132

P2B-132

A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma · Phase II
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania) · Dr. Jansen
consented 2013-07-10

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 febrile neutropenia with onset in cycle 6 (2013-11-22); assessed as related to study drug (probable); resolved 2013-11-29.

moderate assessed

Grade 3 cholecystitis with onset in cycle 4 (2013-09-29); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-10-13.

severe serious under_review

Grade 2 mucosal inflammation with onset in cycle 3 (2013-09-16); assessed as related to study drug (probable); resolved 2013-09-22.

moderate assessed

Grade 1 constipation with onset in cycle 2 (2013-08-20); assessed as not related to study drug (not related); resolved 2013-08-23.

mild assessed

Grade 4 neutropenia with onset in cycle 1 (2013-08-05); assessed as related to study drug (probable); resolved 2013-08-11; action: drug interrupted.

severe assessed

Grade 3 febrile neutropenia with onset in cycle 1 (2013-08-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-10.

severe serious assessed

Grade 3 mucosal inflammation with onset in cycle 1 (2013-08-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-13.

severe serious assessed

Data queries

Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-132 occurred on 2013-09-08, 4 d late against planned day 43 (2013-09-04 ± 3 d, anchored on first dose 2013-07-24). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open

Visit Cycle 2 Day 1: infusion (V3) for P2B-132 occurred on 2013-08-18, 4 d late against planned day 22 (2013-08-14 ± 3 d, anchored on first dose 2013-07-24). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V3] open

AE Neutropenia (grade 4) for P2B-132 (onset 2013-08-05) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Neutropenia 2013-08-05] open