WHO ICTRP trial
An open-label randomized multicentre phase III study of trastuzumab in…
EUCTR2005-000387-39-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2005-000387-39-GB |
|---|---|
| Public title | An open-label randomized multicentre phase III study of trastuzumab in combination with a fluoropyrimidine and cisplatin versus chemotherapy alone as first-line therapy in patients with HER2 positive advanced gastric cancer. |
| Scientific title | An open-label randomized multicentre phase III study of trastuzumab in combination with a fluoropyrimidine and cisplatin versus chemotherapy alone as first-line therapy in patients with HER2 positive advanced gastric cancer. |
| Primary sponsor | Hoffmann-La Roche Ltd/Inc/AG/Roche Global Development |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;Finland;Belgium;Spain;Denmark;Germany;Italy;United Kingdom |
| Conditions | Advanced gastric cancer MedDRA version: 7.1 Level: PT Classification code 10017767 |
| Interventions | Trade Name: Herceptin Product Name: Herceptin Product Code: RO 45-2317 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: trastuzumab Current Sponsor code: RO 45-2317 Concentration unit: mg milligram(s) Concentration… |
| Registration date | Jun 21, 2005 |
| Target size | 584 |
| Secondary IDs | BO18255;2005-000387-39-FI |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: