P2B-069

CTRC Institute for Drug Development, University of Texas (San Antonio, TX) › P2B-069

P2B-069

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 2013-01-15

completed

AEs

11

Serious

0

Dropout signal

–

Adverse events

11

Grade 3 pain in extremity with onset in cycle 6 (2013-06-04); assessed as not related to study drug (not related); resolved 2013-06-24.

severe assessed

Grade 1 abdominal pain with onset in cycle 6 (2013-06-02); assessed as not related to study drug (not related); resolved 2013-06-07.

mild assessed

Grade 1 nausea with onset in cycle 5 (2013-05-02); assessed as not related to study drug (not related); resolved 2013-05-07.

mild assessed

Grade 1 fatigue with onset in cycle 4 (2013-04-24); assessed as not related to study drug (not related); resolved 2013-05-22.

mild assessed

Grade 1 constipation with onset in cycle 4 (2013-04-08); assessed as not related to study drug (unlikely); resolved 2013-04-12.

mild assessed

Grade 1 dyspnoea with onset in cycle 3 (2013-04-07); assessed as not related to study drug (not related); resolved 2013-05-02.

mild assessed

Grade 1 vomiting with onset in cycle 3 (2013-03-22); assessed as not related to study drug (unlikely); resolved 2013-03-23.

mild assessed

Grade 2 stomatitis with onset in cycle 2 (2013-03-06); assessed as related to study drug (probable); resolved 2013-03-11.

moderate assessed

Grade 1 diarrhoea with onset in cycle 2 (2013-03-04); assessed as not related to study drug (not related); resolved 2013-03-08.

mild assessed

Grade 2 neutropenia with onset in cycle 2 (2013-03-03); assessed as related to study drug (probable); resolved 2013-03-12.

moderate assessed

Grade 2 alopecia with onset in cycle 1 (2013-02-15); 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.