P2B-125

Royal Hobart Hospital (Hobart, Australia) › P2B-125

P2B-125

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
Royal Hobart Hospital (Hobart, Australia) · Dr. Novak
consented 2013-06-26

withdrawn

AEs

5

Serious

1

Dropout signal

–

Adverse events

5

Grade 3 asthenia with onset in cycle 4 (2013-10-12); assessed as not related to study drug (unlikely); resolved 2013-11-10; action: drug interrupted.

severe assessed

Grade 1 fatigue with onset in cycle 2 (2013-08-10); assessed as not related to study drug (not related); resolved 2013-09-06.

mild assessed

Grade 1 vomiting with onset in cycle 2 (2013-08-02); assessed as not related to study drug (not related); resolved 2013-08-05.

mild assessed

Grade 3 transient ischaemic attack with onset in cycle 2 (2013-07-31); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-08-02.

severe serious assessed

Grade 1 constipation with onset in cycle 2 (2013-07-30); assessed as not related to study drug (unlikely); resolved 2013-08-04.

mild assessed

Data queries

2

Visit Cycle 4 Day 1: infusion (V5) for P2B-125 occurred on 2013-10-01, 20 d late against planned day 64 (2013-09-11 ± 3 d, anchored on first dose 2013-07-10). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open

Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-125 occurred on 2013-09-03, 13 d late against planned day 43 (2013-08-21 ± 3 d, anchored on first dose 2013-07-10). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open