P2B-078

Sarcoma Oncology Center (Santa Monica, CA) › P2B-078

P2B-078

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
Sarcoma Oncology Center (Santa Monica, CA) · Dr. Reyes
consented 2013-02-17

completed

AEs

3

Serious

0

Dropout signal

–

Adverse events

3

Grade 2 stomatitis with onset in cycle 3 (2013-05-02); assessed as related to study drug (probable); resolved 2013-05-09.

moderate assessed

Grade 1 nausea with onset in cycle 1 (2013-03-09); assessed as not related to study drug (not related); resolved 2013-03-11.

mild assessed

Grade 2 vomiting with onset in cycle 1 (2013-03-08); assessed as not related to study drug (not related); resolved 2013-03-09.

moderate assessed

Data queries

2

Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-078 occurred on 2013-04-27, 10 d late against planned day 43 (2013-04-17 ± 3 d, anchored on first dose 2013-03-06). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open

Visit Cycle 2 Day 1: infusion (V3) for P2B-078 occurred on 2013-04-01, 5 d late against planned day 22 (2013-03-27 ± 3 d, anchored on first dose 2013-03-06). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V3] open