open label, randomized, pilot study on the activity of olanzapine with or without delayed dexamenthasone versus dexamenthasone alone for the prevention of delayed nausea and vomiting in patients with gynecologic cancers receiving carboplatin and paclitaxel-based chemotherapy and guidline-directed prophylactic anti-emetics

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005309-30-IT

Enrollment

Registered

2014-01-14

Start date

2014-03-13

Completion date

Unknown

Last updated

2018-03-05

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

Conditions

Patients with gynecologic tumors candidate to chemotherapy with carboplatinum and paclitaxel

Interventions

Trade Name: ZYPREXA Product Name: ZYPREXA Product Code: N05AH03 Pharmaceutical Form: Tablet INN or Proposed INN: OLANZAPINE CAS Number: 132539-06-1 Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patient with diagnosis of gynecologic cancer not pretreate with chemoterapy 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: patients scheduled to receive chemotherapy, brain metastases, patients who receive another antipsychotic agent, performance status >2

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of complete anti emetic protection ;Secondary Objective: Complete Protection, CC , CR;Primary end point(s): CP;Timepoint(s) of evaluation of this end point: 5 day from 1st cycle of chemotherapy	—

Secondary

Measure	Time frame
Secondary end point(s): Complete response, CC, CR;Timepoint(s) of evaluation of this end point: 5 day from 1st cycle of chemotherapy	—

Countries

Italy

Contacts

Public ContactINT

Fondazione IRCCS Istituto Nazionale dei Tumori

00390223902546

Outcome results

None listed

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