P2B-133

State Health Centre Oncology Department (Budapest, Hungary) › P2B-133

P2B-133

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 2013-07-12

completed

AEs

3

Serious

0

Dropout signal

–

Adverse events

3

Grade 1 hypoalbuminaemia with onset in cycle 4 (2013-10-15); assessed as not related to study drug (unlikely); resolved 2013-11-27.

mild assessed

Grade 2 alopecia with onset in cycle 2 (2013-08-27); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 2 nausea with onset in cycle 1 (2013-07-22); assessed as not related to study drug (not related); resolved 2013-07-26.

moderate assessed

Data queries

3

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-133 occurred on 2013-11-13, 9 d late against planned day 106 (2013-11-04 ± 3 d, anchored on first dose 2013-07-22). 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-133 occurred on 2013-10-24, 10 d late against planned day 85 (2013-10-14 ± 3 d, anchored on first dose 2013-07-22). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-133 occurred on 2013-10-04, 11 d late against planned day 64 (2013-09-23 ± 3 d, anchored on first dose 2013-07-22). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open