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Application of Aprepitant as salvage prophylaxis after failure of a conventional antiemetic therapy during moderately emetogenic chemotherapy in gastrointestinal cancer - EMEND_GI

Application of Aprepitant as salvage prophylaxis after failure of a conventional antiemetic therapy during moderately emetogenic chemotherapy in gastrointestinal cancer - EMEND_GI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-003783-30-DE
Enrollment
Unknown
Registered
2005-02-23
Start date
2005-04-27
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

Chemotherapy-induced nasuea and vomiting (CINV)

Interventions

Trade Name: EMEND Product Name: Emend Pharmaceutical Form: Capsule, hard INN or Proposed INN: Aprepitant Current Sponsor code: EU/1/03/262/001 Other descriptive name: EMEND Concentration unit: mg/kg m

Sponsors

Technical Unversity of Munich
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Treatment of any tumor in the gastrointestinal tract with moderately emetogenic chemotherapy. Failure of a adequate standard prophylaxis 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: Treatment of any tumor in the gastrointestinal tract with delayed CINV after day 5. Past treatment with CINV >/= degree 2. Known incompatibility compared to study medication. Failure competency of the patient as to protocol instruction. Patients with childbearing potential or lactation.

Design outcomes

Primary

MeasureTime frame
Main Objective: Assessment of the protection from by acute and delayed nausea an emesis on days 1-5 of a moderately emetogenic chemotherapy cycle. Partial response is defined as: decrease of the severity ofnausea and emesis of at least one grade according to the NCI.CTC classification. ;Secondary Objective: Assessment of protection from acute nausea and emesis on day 1. Assessment of protection from delayed nausea and emesis on days 2-5. Safety and efficacy for higher dosages of aprepitant. Assessment of potential risk factor for CINV. Assessment of adverse effects. Incidence of nausea and emesis. Pharmacoeconomic analysis. ;Primary end point(s): Assessment of the protection from by acute and delayed nausea an emesis on days 1-5 of a moderately emetogenic chemotherapy cycle. Partial response is defined as: decrease of the severity ofnausea and emesis of at least one grade according to the NCI.CTC classification.—

Countries

Germany

Outcome results

None listed

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