Sarcoma Oncology Center (Santa Monica, CA) › P2B-104

P2B-104

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
Sarcoma Oncology Center (Santa Monica, CA) · Dr. Reyes
consented 2013-04-25

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 nausea with onset in cycle 6 (2013-08-31); assessed as not related to study drug (not related); resolved 2013-09-05.

mild assessed

Grade 2 stomatitis with onset in cycle 5 (2013-08-17); assessed as related to study drug (probable); resolved 2013-08-26.

moderate assessed

Grade 4 neutropenia with onset in cycle 5 (2013-08-12); assessed as related to study drug (probable); resolved 2013-08-17; action: drug interrupted.

severe assessed

Grade 3 vomiting with onset in cycle 5 (2013-08-10); serious (hospitalization); assessed as related to study drug (possible); resolved 2013-08-13; action: drug interrupted.

severe serious assessed

Grade 2 anaemia with onset in cycle 4 (2013-07-27); assessed as related to study drug (probable); resolved 2013-08-24.

moderate assessed

Grade 1 vomiting with onset in cycle 4 (2013-07-18); assessed as not related to study drug (unlikely); resolved 2013-07-19.

mild assessed

Grade 1 cough with onset in cycle 2 (2013-06-18); assessed as not related to study drug (not related); resolved 2013-06-25.

mild assessed

Grade 2 pyrexia with onset in cycle 1 (2013-05-19); assessed as not related to study drug (unlikely); resolved 2013-05-22.

moderate assessed

Data queries

AE Neutropenia (grade 4) for P2B-104 (onset 2013-08-12) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Neutropenia 2013-08-12] open