A Phase II Study of 1-(2-chloroethyl)-1-nitroso-3-(2-hydroxyethyl)-urea (HECNU) in pancreatic cancer - Phase II trial with FFC33

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000590-21-AT

Enrollment

Registered

2005-07-20

Start date

2005-08-24

Completion date

Unknown

Last updated

2026-03-09

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

Conditions

Pancreatic cancer

Interventions

Product Name: 1-(2-chloroethyl)-1-nitroso-3-(2-hydroxyethyl)-urea Product Code: FFC33 Pharmaceutical Form: Powder for injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Female and male patients aged over 18 years with confirmed progressive pancreatic cancer, who have already had surgery and/or any other chemotherapy. Life expectancy of > 3 months. 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: No cancer treatment within four weeks of study entry (within 6 weeks for treatment withmitomycin C). No previous treatment with nitrosoureas, dacarbazine, procarbazime or temozolomide before admission to the study. No major impairment to liver, heart, kidney function.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy;Secondary Objective: Survival, qualitative and quantitative toxic effects, time to progression, overall survival;Primary end point(s): Anti tumour response (response rate compared to baseline)	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 14, 2026