CTRC Institute for Drug Development, University of Texas (San Antonio, TX) › P2B-028

P2B-028

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 2012-08-11

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 neutropenia with onset in cycle 6 (2012-12-13); assessed as related to study drug (probable); resolved 2012-12-23; action: drug interrupted.

severe assessed

Grade 1 aspartate aminotransferase increased with onset in cycle 6 (2012-12-10); assessed as not related to study drug (unlikely); resolved 2012-12-31.

mild assessed

Grade 2 pertussis with onset in cycle 6 (2012-12-07); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-12-18.

moderate serious assessed

Grade 3 cholecystitis acute with onset in cycle 5 (2012-12-02); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-12-14; action: drug interrupted.

severe serious assessed

Grade 1 asthenia with onset in cycle 5 (2012-11-24); assessed as not related to study drug (not related); resolved 2012-12-23.

mild assessed

Grade 2 constipation with onset in cycle 5 (2012-11-15); assessed as not related to study drug (not related); resolved 2012-11-19.

moderate assessed

Grade 3 anaemia with onset in cycle 4 (2012-11-05); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-02.

severe serious assessed

Grade 1 hypocalcaemia with onset in cycle 4 (2012-11-05); assessed as not related to study drug (not related); resolved 2012-11-12.

mild assessed

Grade 2 nausea with onset in cycle 4 (2012-10-27); assessed as not related to study drug (unlikely); resolved 2012-10-29.

moderate assessed

Grade 2 anaemia with onset in cycle 2 (2012-09-27); assessed as related to study drug (probable); resolved 2012-10-27.

moderate assessed

Grade 2 pyrexia with onset in cycle 2 (2012-09-23); assessed as not related to study drug (unlikely); resolved 2012-09-26.

moderate assessed

Grade 3 pneumonia with onset in cycle 1 (2012-08-28); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-09-07.

severe serious assessed

Grade 2 constipation with onset in cycle 1 (2012-08-24); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-08-31.

moderate serious assessed

Data queries

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