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axintotecan - Non-Interventional Observational Study (registration title with ECs and CA). Axinotecan for the treatment of malignant neoplasms of the rectum with therapy regimens involving axintotecan (generic name: irinotecan) (study title explained).

axintotecan - Non-Interventional Observational Study (registration title with ECs and CA). Axinotecan for the treatment of malignant neoplasms of the rectum with therapy regimens involving axintotecan (generic name: irinotecan) (study title explained).

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00004747
Enrollment
500
Registered
2013-02-22
Start date
2011-09-05
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

C20 C19

Interventions

Group 1: Efficaciy will be assessed and documented in the CRF by: - clinical examination - imaging measures - tumor speciation laboratory Tolerability will be assessed and documented in the CRF by: -

Sponsors

AxioNovo Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Informed Consent

Exclusion criteria

Exclusion criteria: Missing Informed Consent

Design outcomes

Secondary

MeasureTime frame
- Diarrhea or neutropenia Toxicity grade 4 during therapy as assessed by clinical examination or laboratory at the end of each cycle and unscheduled visits. - Intolerability in general surveyed at the end of each cycle and unscheduled visits.—

Primary

MeasureTime frame
- Progression during therapy by clinical examination, imaging, or special laboratory at the end of each cycle and during unscheduled visits—

Countries

Germany

Contacts

Public ContactBurkard Heckelbacher

Datafaber GbR

heckelbacher@datafaber.de+49 8161 885 107

Outcome results

None listed

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