University of Iowa (Iowa City, IA) › P2B-003

P2B-003

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
University of Iowa (Iowa City, IA) · Dr. Okafor
consented 2012-03-13

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 hypoalbuminaemia with onset in cycle 6 (2012-08-01); assessed as not related to study drug (unlikely); resolved 2012-08-28.

moderate assessed

Grade 2 vomiting with onset in cycle 4 (2012-05-31); assessed as not related to study drug (not related); resolved 2012-06-01.

moderate assessed

Grade 3 anaemia with onset in cycle 3 (2012-05-15); assessed as related to study drug (probable); resolved 2012-06-03.

severe assessed

Grade 1 pyrexia with onset in cycle 1 (2012-04-10); assessed as not related to study drug (not related); resolved 2012-04-14.

mild assessed

Grade 1 alanine aminotransferase increased with onset in cycle 1 (2012-04-09); assessed as not related to study drug (not related); resolved 2012-04-16.

mild assessed

Grade 4 neutropenia with onset in cycle 1 (2012-04-03); assessed as related to study drug (probable); resolved 2012-04-12.

severe assessed

Data queries

Temperature 3.7 C is below the plausible minimum 34 C.

F.VS.TEMP (Temperature) open

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-003 occurred on 2012-07-17, 6 d late against planned day 106 (2012-07-11 ± 3 d, anchored on first dose 2012-03-28). 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-003 occurred on 2012-06-26, 6 d late against planned day 85 (2012-06-20 ± 3 d, anchored on first dose 2012-03-28). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

AE Neutropenia (grade 4) for P2B-003 (onset 2012-04-03) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Neutropenia 2012-04-03] open