The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia)

Sites / AUS

The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia)

AUS · PI Dr. Kowalski · activated

KRI 0.276

Patients

5

Active

0

Serious AEs

4

Open QA

0

Aged queries

0

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 · 83000 USD

executed

Patients

5

P2B-030

screened

P2B-049

completed

P2B-075

completed

P2B-112

completed

P2B-123

completed

Safety

23 AEs · 4 serious

Grade 3 stomatitis with onset in cycle 1 (2013-02-28); serious (hospitalization); assessed as related to study drug (probable); not resolved at last follow-up.

serious P2B-075

Grade 5 septic shock with onset in cycle 1 (2013-02-27); serious (death; life-threatening; hospitalization); assessed as related to study drug (probable); fatal outcome on 2013-03-01.

serious P2B-075

Grade 4 febrile neutropenia with onset in cycle 1 (2013-02-26); serious (hospitalization); assessed as related to study drug (probable); not resolved at last follow-up; action: drug interrupted.

serious P2B-075

Grade 3 dehydration with onset in cycle 1 (2013-02-25); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-02-28.

serious P2B-075

QA findings

0 open

STUDY DRUG ADMINISTRATION DEVIATION: Infusion duration outside protocol (aldoxorubicin 30 min / doxorubicin per label) or incorrect BSA used for dose calculation (subject P2B-123, 2013-10-14)

resolved minor

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-112, 2013-07-31)

resolved minor

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-049, 2013-02-08)

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