Blokhin Cancer Research Center (Moscow, Russia) › P2B-018

P2B-018

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
Blokhin Cancer Research Center (Moscow, Russia) · Dr. Moreau
consented 2012-07-12

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 hypoalbuminaemia with onset in cycle 6 (2012-11-21); assessed as not related to study drug (not related); resolved 2012-12-23.

moderate assessed

Grade 1 hypocalcaemia with onset in cycle 5 (2012-11-03); assessed as not related to study drug (unlikely); resolved 2012-11-23.

mild assessed

Grade 2 weight decreased with onset in cycle 5 (2012-11-01); assessed as not related to study drug (unlikely); resolved 2012-12-17.

moderate assessed

Grade 3 diarrhoea with onset in cycle 3 (2012-09-22); serious (hospitalization); assessed as related to study drug (possible); resolved 2012-09-24; action: drug interrupted.

severe serious assessed

Grade 2 fatigue with onset in cycle 2 (2012-08-30); assessed as not related to study drug (not related); resolved 2012-09-13.

moderate assessed

Grade 2 hypokalaemia with onset in cycle 2 (2012-08-27); assessed as not related to study drug (unlikely); resolved 2012-08-30.

moderate assessed

Grade 2 alopecia with onset in cycle 1 (2012-08-16); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 2 diarrhoea with onset in cycle 1 (2012-08-08); assessed as not related to study drug (unlikely); resolved 2012-08-14.

moderate assessed

Data queries

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-018 occurred on 2012-11-18, 4 d late against planned day 106 (2012-11-14 ± 3 d, anchored on first dose 2012-08-01). 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-018 occurred on 2012-10-29, 5 d late against planned day 85 (2012-10-24 ± 3 d, anchored on first dose 2012-08-01). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-018 occurred on 2012-10-08, 5 d late against planned day 64 (2012-10-03 ± 3 d, anchored on first dose 2012-08-01). 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-018 occurred on 2012-09-17, 5 d late against planned day 43 (2012-09-12 ± 3 d, anchored on first dose 2012-08-01). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open