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Phase II study of Brostallicin a(PNU- 166196) and Cisplatin (CDDP) in Adult Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)preceded by a dose-escalation component

Phase II study of Brostallicin a(PNU- 166196) and Cisplatin (CDDP) in Adult Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)preceded by a dose-escalation component

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004557-25-IT
Enrollment
Unknown
Registered
2005-08-11
Start date
2005-06-03
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Use in combination with cisplatin for the treatment of recurrent squamous cell carcinoma of the head and neck MedDRA version: 6.1 Level: HLT Classification code 10024530

Interventions

Product Name: Brostallicin Product Code: PNU-166196 Pharmaceutical Form: Powder for solution for injection CAS Number: 203158-60-0 Current Sponsor code: PNU-166196 Concentration unit: mg milligram(s)

Sponsors

NERVIANO MEDICAL SCIENCE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026