University of Iowa (Iowa City, IA)

Sites / USA

University of Iowa (Iowa City, IA)

USA · PI Dr. Okafor · activated

KRI 0.218

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 · 83000 USD

executed

Patients

5

P2B-003

completed

P2B-004

completed

P2B-027

screened

P2B-106

completed

P2B-120

completed

Safety

21 AEs · 3 serious

Grade 3 pelvic neoplasm with onset in cycle 2 (2013-06-12); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-22.

serious P2B-106

Grade 3 deep vein thrombosis with onset in cycle 2 (2013-06-03); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-22; action: drug interrupted.

serious P2B-106

Grade 3 leukopenia with onset in cycle 1 (2013-05-17); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-05-24.

serious P2B-106

QA findings

0 open

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-004, 2012-07-23)

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