Sarcoma Oncology Center (Santa Monica, CA) › P2B-062

P2B-062

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 2012-12-19

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 atrial fibrillation with onset in cycle 6 (2013-05-16); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-05-19.

severe serious assessed

Grade 3 pneumothorax with onset in cycle 6 (2013-05-13); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-05-25; action: drug interrupted.

severe serious assessed

Grade 2 fatigue with onset in cycle 5 (2013-04-27); assessed as not related to study drug (unlikely); resolved 2013-05-26.

moderate assessed

Grade 1 diarrhoea with onset in cycle 5 (2013-04-23); assessed as not related to study drug (not related); resolved 2013-04-28.

mild assessed

Grade 2 neutropenia with onset in cycle 2 (2013-02-17); assessed as related to study drug (probable); resolved 2013-02-24.

moderate assessed

Grade 1 alopecia with onset in cycle 1 (2013-01-23); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed

Grade 2 diarrhoea with onset in cycle 1 (2013-01-19); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-01-21.

moderate serious assessed

Grade 2 leukopenia with onset in cycle 1 (2013-01-17); assessed as related to study drug (probable); resolved 2013-01-26.

moderate assessed

Data queries

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-062 occurred on 2013-05-04, 10 d late against planned day 106 (2013-04-24 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V7] open

Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-062 occurred on 2013-04-13, 10 d late against planned day 85 (2013-04-03 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-062 occurred on 2013-03-23, 10 d late against planned day 64 (2013-03-13 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open

Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-062 occurred on 2013-03-03, 11 d late against planned day 43 (2013-02-20 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open

Visit Cycle 2 Day 1: infusion (V3) for P2B-062 occurred on 2013-02-11, 12 d late against planned day 22 (2013-01-30 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V3] open