P2B-010

State Health Centre Oncology Department (Budapest, Hungary) › P2B-010

P2B-010

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 2012-06-13

completed

AEs

4

Serious

1

Dropout signal

–

Adverse events

4

Grade 1 decreased appetite with onset in cycle 5 (2012-10-07); assessed as not related to study drug (not related); resolved 2012-10-29.

mild assessed

Grade 1 stomatitis with onset in cycle 5 (2012-09-25); assessed as related to study drug (probable); resolved 2012-10-02.

mild assessed

Grade 2 anaemia with onset in cycle 3 (2012-08-16); assessed as related to study drug (probable); resolved 2012-09-02.

moderate assessed

Grade 3 leukocytosis with onset in cycle 2 (2012-07-22); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-07-27; action: dose reduced.

severe serious assessed

Data queries

2

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-010 occurred on 2012-10-13, 9 d late against planned day 106 (2012-10-04 ± 3 d, anchored on first dose 2012-06-21). 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-010 occurred on 2012-09-21, 8 d late against planned day 85 (2012-09-13 ± 3 d, anchored on first dose 2012-06-21). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open