CTRC Institute for Drug Development, University of Texas (San Antonio, TX) › P2B-117

P2B-117

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 2013-05-24

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 anaemia with onset in cycle 1 (2013-06-20); assessed as related to study drug (probable); resolved 2013-07-09.

moderate assessed

Grade 3 vomiting with onset in cycle 1 (2013-06-17); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-24; action: drug withdrawn.

severe serious assessed

Grade 2 leukopenia with onset in cycle 1 (2013-06-16); assessed as related to study drug (probable); resolved 2013-06-22.

moderate assessed

Grade 1 stomatitis with onset in cycle 1 (2013-06-14); assessed as related to study drug (probable); resolved 2013-06-23.

mild assessed

Grade 3 gastrointestinal haemorrhage with onset in cycle 1 (2013-06-09); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-14; action: drug interrupted.

severe serious assessed

Grade 3 leukopenia with onset in cycle 1 (2013-06-09); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-18; action: dose reduced.

severe serious assessed

Grade 1 vomiting with onset in cycle 1 (2013-06-06); assessed as not related to study drug (not related); resolved 2013-06-08.

mild assessed

Grade 1 cough with onset in cycle 1 (2013-06-04); assessed as not related to study drug (not related); resolved 2013-06-29.

mild assessed

Grade 2 nausea with onset in cycle 1 (2013-06-03); assessed as not related to study drug (unlikely); resolved 2013-06-04.

moderate assessed

Data queries

No data queries. Open queries would appear here for this patient.