P2B-139

Sarcoma Oncology Center (Santa Monica, CA) › P2B-139

P2B-139

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 2013-07-24

completed

AEs

4

Serious

0

Dropout signal

–

Adverse events

4

Grade 2 decreased appetite with onset in cycle 5 (2013-11-10); assessed as not related to study drug (not related); resolved 2013-11-23.

moderate assessed

Grade 1 nausea with onset in cycle 3 (2013-09-20); assessed as not related to study drug (not related); resolved 2013-09-23.

mild assessed

Grade 3 aspartate aminotransferase increased with onset in cycle 2 (2013-09-14); assessed as not related to study drug (unlikely); resolved 2013-09-27; action: drug interrupted.

severe assessed

Grade 2 alopecia with onset in cycle 1 (2013-08-20); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Data queries

0

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