CTRC Institute for Drug Development, University of Texas (San Antonio, TX) › P2B-020

P2B-020

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
CTRC Institute for Drug Development, University of Texas (San Antonio, TX) · Dr. Muller
consented 2012-07-23

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 pyrexia with onset in cycle 4 (2012-10-18); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-10-20.

moderate serious assessed

Grade 4 neutropenia with onset in cycle 4 (2012-10-17); assessed as related to study drug (probable); resolved 2012-10-22; action: drug interrupted.

severe assessed

Grade 1 thrombocytopenia with onset in cycle 4 (2012-10-14); assessed as related to study drug (probable); resolved 2012-10-23.

mild assessed

Grade 3 vomiting with onset in cycle 4 (2012-10-08); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-10-09.

severe serious assessed

Grade 4 febrile neutropenia with onset in cycle 3 (2012-09-26); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-10-05; action: dose reduced.

severe serious assessed

Grade 3 thrombocytopenia with onset in cycle 3 (2012-09-25); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-10-07.

severe serious assessed

Grade 2 anaemia with onset in cycle 2 (2012-09-02); assessed as related to study drug (probable); resolved 2012-09-20.

moderate assessed

Grade 1 weight decreased with onset in cycle 2 (2012-08-28); assessed as not related to study drug (unlikely); resolved 2012-09-24.

mild assessed

Grade 2 vomiting with onset in cycle 2 (2012-08-26); assessed as not related to study drug (unlikely); resolved 2012-08-28.

moderate assessed

Grade 2 febrile neutropenia with onset in cycle 1 (2012-08-15); assessed as related to study drug (probable); resolved 2012-08-20.

moderate assessed

Grade 1 pyrexia with onset in cycle 1 (2012-08-13); assessed as not related to study drug (not related); resolved 2012-08-15.

mild assessed

Grade 2 asthenia with onset in cycle 1 (2012-08-10); assessed as not related to study drug (not related); resolved 2012-09-08.

moderate assessed

Grade 4 hypovolaemic shock with onset in cycle 1 (2012-08-07); serious (life-threatening; hospitalization); assessed as not related to study drug (not related); resolved 2012-08-09; action: drug interrupted.

severe serious assessed

Data queries

AE Neutropenia (grade 4) for P2B-020 (onset 2012-10-17) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Neutropenia 2012-10-17] open