P2B-067

State Health Centre Oncology Department (Budapest, Hungary) › P2B-067

P2B-067

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 2013-01-10

completed

AEs

5

Serious

0

Dropout signal

–

Adverse events

5

Grade 1 decreased appetite with onset in cycle 6 (2013-05-25); assessed as not related to study drug (unlikely); resolved 2013-06-08.

mild assessed

Grade 2 fatigue with onset in cycle 6 (2013-05-16); assessed as not related to study drug (not related); resolved 2013-06-05.

moderate assessed

Grade 3 mucosal inflammation with onset in cycle 5 (2013-04-22); assessed as related to study drug (probable); resolved 2013-04-30.

severe assessed

Grade 2 alopecia with onset in cycle 1 (2013-02-07); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 2 anaemia with onset in cycle 1 (2013-01-28); assessed as related to study drug (probable); resolved 2013-02-17.

moderate assessed

Data queries

4

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-067 occurred on 2013-05-09, 6 d late against planned day 106 (2013-05-03 ± 3 d, anchored on first dose 2013-01-18). 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-067 occurred on 2013-04-17, 5 d late against planned day 85 (2013-04-12 ± 3 d, anchored on first dose 2013-01-18). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-067 occurred on 2013-03-27, 5 d late against planned day 64 (2013-03-22 ± 3 d, anchored on first dose 2013-01-18). 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-067 occurred on 2013-03-06, 5 d late against planned day 43 (2013-03-01 ± 3 d, anchored on first dose 2013-01-18). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open