Royal Hobart Hospital (Hobart, Australia)

Sites / AUS

Royal Hobart Hospital (Hobart, Australia)

AUS · PI Dr. Novak · activated

KRI 0.409

Patients

3

Active

0

Serious AEs

4

Open QA

1

Aged queries

2

Luna users

0

Studies & contracts

1

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 · study completed · 73500 USD

executed

Patients

3

P2B-097

completed

P2B-110

completed

P2B-125

withdrawn

Safety

19 AEs · 4 serious

Grade 3 leukopenia with onset in cycle 6 (2013-09-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-30.

serious P2B-110

Grade 3 pulmonary embolism with onset in cycle 4 (2013-08-16); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-09-04; action: drug interrupted.

serious P2B-110

Grade 3 transient ischaemic attack with onset in cycle 2 (2013-07-31); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-08-02.

serious P2B-125

Grade 3 febrile neutropenia with onset in cycle 1 (2013-06-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-12; action: dose reduced.

serious P2B-110

QA findings

1 open

PROHIBITED CONCOMITANT THERAPY: Other systemic anticancer therapy started while on study treatment (subject P2B-125, 2013-10-12)

open major

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-110, 2013-08-04)

resolved minor

Visits & payments

0

Nothing scheduled. Re-score risk to let the pipeline propose a visit.

Luna participants

0

No Luna participants here yet. Participants join once invited by the site.

Open Luna