Royal Perth Hospital (Perth, Australia) › P2B-036

P2B-036

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
Royal Perth Hospital (Perth, Australia) · Dr. Silva
consented 2012-09-22

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 oedema peripheral with onset in cycle 6 (2013-02-14); assessed as not related to study drug (unlikely); resolved 2013-03-23.

mild assessed

Grade 1 weight decreased with onset in cycle 5 (2013-01-26); assessed as not related to study drug (not related); resolved 2013-02-17.

mild assessed

Grade 1 diarrhoea with onset in cycle 3 (2012-12-03); assessed as not related to study drug (unlikely); resolved 2012-12-09.

mild assessed

Grade 3 febrile neutropenia with onset in cycle 2 (2012-11-02); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-11-09; action: dose reduced.

severe serious assessed

Grade 3 hypersensitivity with onset in cycle 2 (2012-10-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-10-30; action: drug interrupted.

severe serious assessed

Grade 1 alopecia with onset in cycle 1 (2012-10-21); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed

Grade 2 febrile neutropenia with onset in cycle 1 (2012-10-15); assessed as related to study drug (probable); resolved 2012-10-22.

moderate assessed

Data queries

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-036 occurred on 2013-01-27, 10 d late against planned day 106 (2013-01-17 ± 3 d, anchored on first dose 2012-10-04). 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-036 occurred on 2013-01-07, 11 d late against planned day 85 (2012-12-27 ± 3 d, anchored on first dose 2012-10-04). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-036 occurred on 2012-12-16, 10 d late against planned day 64 (2012-12-06 ± 3 d, anchored on first dose 2012-10-04). 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-036 occurred on 2012-11-25, 10 d late against planned day 43 (2012-11-15 ± 3 d, anchored on first dose 2012-10-04). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open