P2B-073

Stanford University (Stanford, CA) › P2B-073

P2B-073

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
Stanford University (Stanford, CA) · Dr. Nolan
consented 2013-02-02

completed

AEs

4

Serious

0

Dropout signal

–

Adverse events

4

Grade 2 stomatitis with onset in cycle 6 (2013-06-21); assessed as related to study drug (probable); resolved 2013-07-01.

moderate assessed

Grade 3 anaemia with onset in cycle 5 (2013-05-30); assessed as related to study drug (probable); resolved 2013-06-23.

severe assessed

Grade 2 leukopenia with onset in cycle 1 (2013-03-05); assessed as related to study drug (probable); resolved 2013-03-15.

moderate assessed

Grade 1 neutropenia with onset in cycle 1 (2013-03-03); assessed as related to study drug (probable); resolved 2013-03-13.

mild assessed

Data queries

2

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-073 occurred on 2013-06-15, 9 d late against planned day 106 (2013-06-06 ± 3 d, anchored on first dose 2013-02-21). 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-073 occurred on 2013-05-26, 10 d late against planned day 85 (2013-05-16 ± 3 d, anchored on first dose 2013-02-21). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open