P2B-031

Royal North Shore (St Leonards, Australia) › P2B-031

P2B-031

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 North Shore (St Leonards, Australia) · Dr. Rossi
consented 2012-09-03

completed

AEs

2

Serious

0

Dropout signal

–

Adverse events

2

Grade 1 nausea with onset in cycle 2 (2012-10-13); assessed as not related to study drug (unlikely); resolved 2012-10-18.

mild assessed

Grade 2 alopecia with onset in cycle 1 (2012-10-03); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Data queries

2

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-031 occurred on 2013-01-11, 9 d late against planned day 106 (2013-01-02 ± 3 d, anchored on first dose 2012-09-19). 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-031 occurred on 2012-12-21, 9 d late against planned day 85 (2012-12-12 ± 3 d, anchored on first dose 2012-09-19). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open