P2B-059

State Health Centre Oncology Department (Budapest, Hungary) › P2B-059

P2B-059

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
State Health Centre Oncology Department (Budapest, Hungary) · Dr. Clarke
consented 2012-12-10

completed

AEs

6

Serious

2

Dropout signal

–

Adverse events

6

Grade 1 decreased appetite with onset in cycle 6 (2013-04-18); assessed as not related to study drug (not related); resolved 2013-05-18.

mild assessed

Grade 4 febrile neutropenia with onset in cycle 3 (2013-02-11); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-02-20; action: dose reduced.

severe serious assessed

Grade 3 anaemia with onset in cycle 3 (2013-02-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-03-08; action: drug interrupted.

severe serious assessed

Grade 3 nausea with onset in cycle 3 (2013-02-02); assessed as not related to study drug (unlikely); resolved 2013-02-03; action: drug interrupted.

severe assessed

Grade 1 anaemia with onset in cycle 2 (2013-01-13); assessed as related to study drug (probable); resolved 2013-02-08.

mild assessed

Grade 2 febrile neutropenia with onset in cycle 1 (2012-12-24); assessed as related to study drug (probable); resolved 2013-01-02.

moderate assessed

Data queries

3

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-059 occurred on 2013-04-14, 12 d late against planned day 106 (2013-04-02 ± 3 d, anchored on first dose 2012-12-18). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V7] open

Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-059 occurred on 2013-03-24, 12 d late against planned day 85 (2013-03-12 ± 3 d, anchored on first dose 2012-12-18). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-059 occurred on 2013-03-04, 13 d late against planned day 64 (2013-02-19 ± 3 d, anchored on first dose 2012-12-18). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open