Delhi State Cancer Institute (Mandoli, India)

Sites / IND

Delhi State Cancer Institute (Mandoli, India)

IND · PI Dr. Muller · activated

KRI 0.0

Patients

2

Active

0

Serious AEs

3

Open QA

1

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 · 64000 USD

executed

Patients

2

P2B-105

completed

P2B-114

withdrawn

Safety

7 AEs · 3 serious

Grade 4 pancytopenia with onset in cycle 6 (2013-09-18); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-26.

serious P2B-105

Grade 3 gastritis with onset in cycle 5 (2013-08-16); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-08-26.

serious P2B-105

Grade 3 anaemia with onset in cycle 4 (2013-08-13); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-29.

serious P2B-105

QA findings

1 open

ELIGIBILITY CRITERIA NOT MET: Eligibility deviation found after randomization: prior anthracycline exposure above the 225 mg/m2 limit documented in outside records (subject P2B-114, 2013-06-17)

open major

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-114, 2013-06-03)

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