CTRC Institute for Drug Development, University of Texas (San Antonio, TX) › P2B-102

P2B-102

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 2013-04-18

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 anaemia with onset in cycle 4 (2013-07-26); assessed as related to study drug (probable); resolved 2013-08-05.

mild assessed

Grade 3 anaemia with onset in cycle 4 (2013-07-16); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-07-23; action: drug withdrawn.

severe serious assessed

Grade 2 asthenia with onset in cycle 4 (2013-07-16); assessed as not related to study drug (not related); resolved 2013-08-09.

moderate assessed

Grade 2 vomiting with onset in cycle 3 (2013-06-23); assessed as not related to study drug (unlikely); resolved 2013-06-25.

moderate assessed

Grade 1 nausea with onset in cycle 3 (2013-06-22); assessed as not related to study drug (not related); resolved 2013-06-23.

mild assessed

Grade 2 febrile neutropenia with onset in cycle 2 (2013-06-10); assessed as related to study drug (probable); resolved 2013-06-15.

moderate assessed

Grade 1 alopecia with onset in cycle 1 (2013-05-27); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed

Grade 3 febrile neutropenia with onset in cycle 1 (2013-05-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-05-28; action: drug interrupted.

severe serious assessed

Data queries

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