A study that investigates whether ranitidine has a added value in the prevention of paclitaxel-induced allergic reactions

Phase 1

• Conditions: Paclitaxel-induced hypersensitivity reactions; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2017-003535-11-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-27
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 554

Inclusion Criteria

•Age =18 years;
•Able and willing to give written informed consent;
•Planned treatment with regular paclitaxel based chemotherapy for any indication and with any dose.
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 189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 365

Exclusion Criteria

•Prior treatment with a paclitaxel based regimen;
•Known hypersensitivity to paclitaxel, carboplatin, docetaxel, ranitidine, dexamethasone, clemastine, granisetron, ondansetron or excipients;
•Unwilling to stop the use of H2-antagonists for gastroduodenal reflux and ulcer disease. The H2-antagonist should be stopped at least two days before the first paclitaxel infusion (washout). Switching an H2-antagonist to a proton pump inhibitor is allowed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified