Stanford University (Stanford, CA)

Sites / USA

Stanford University (Stanford, CA)

USA · PI Dr. Nolan · activated

KRI 0.237

Patients

5

Active

0

Serious AEs

3

Open QA

0

Aged queries

3

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 · 92500 USD

executed

Patients

5

P2B-014

completed

P2B-019

completed

P2B-073

completed

P2B-092

completed

P2B-111

completed

Safety

25 AEs · 3 serious

Grade 3 pulmonary embolism with onset in cycle 1 (2012-08-01); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-08-21.

serious P2B-019

Grade 3 febrile neutropenia with onset in cycle 1 (2012-07-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-08-02.

serious P2B-019

Grade 3 dehydration with onset in cycle 1 (2012-07-23); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-07-26.

serious P2B-019

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-014, 2012-08-19)

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