State Health Centre Oncology Department (Budapest, Hungary) › P2B-087

P2B-087

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 2013-03-14

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 anaemia with onset in cycle 6 (2013-08-01); assessed as related to study drug (probable); resolved 2013-08-21.

mild assessed

Grade 1 hypocalcaemia with onset in cycle 5 (2013-07-25); assessed as not related to study drug (unlikely); resolved 2013-08-08.

mild assessed

Grade 2 decreased appetite with onset in cycle 5 (2013-07-20); assessed as not related to study drug (not related); resolved 2013-08-18.

moderate assessed

Grade 3 stomatitis with onset in cycle 4 (2013-06-15); assessed as related to study drug (probable); resolved 2013-06-20.

severe assessed

Grade 1 nausea with onset in cycle 4 (2013-06-12); assessed as not related to study drug (unlikely); resolved 2013-06-16.

mild assessed

Data queries

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-087 occurred on 2013-07-30, 21 d late against planned day 106 (2013-07-09 ± 3 d, anchored on first dose 2013-03-26). 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-087 occurred on 2013-07-10, 22 d late against planned day 85 (2013-06-18 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-087 occurred on 2013-06-08, 11 d late against planned day 64 (2013-05-28 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open

Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-087 occurred on 2013-05-17, 10 d late against planned day 43 (2013-05-07 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open

Visit Cycle 2 Day 1: infusion (V3) for P2B-087 occurred on 2013-04-25, 9 d late against planned day 22 (2013-04-16 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V3] open