WHO ICTRP trial
A Phase 2 Randomized Open Label Study of Neratinib versus Lapatinib plus…
EUCTR2008-005425-11-HU · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2008-005425-11-HU |
|---|---|
| Public title | A Phase 2 Randomized Open Label Study of Neratinib versus Lapatinib plus Capecitabine for the treatment of ErbB-2 Positive Locally Advanced or Metastatic Breast Cancer |
| Scientific title | A Phase 2 Randomized Open Label Study of Neratinib versus Lapatinib plus Capecitabine for the Treatment of ErbB-2 Positive Locally Advanced or Metastatic Breast Cancer - Not available |
| Primary sponsor | Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA |
| 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): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Serbia;United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Russian Federation;Italy;Switzerland;France;Jordan;Australia;South Africa;Netherlands;Korea, Republic of;Slovenia;Austria;United… |
| Conditions | Locally advanced or metastatic breast cancer MedDRA version: 14.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)… |
| Interventions | Product Name: neratinib Product Code: HKI-272 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: neratinib CAS Number: 698387-09-06 Current Sponsor code: WAY-179272-B Concentration unit: mg milligram(s) Concentration type: equal… |
| Registration date | Jul 11, 2008 |
| Target size | 233 |
| Secondary IDs | 3144A2-3003/B1891003 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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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: