WHO ICTRP trial
The purpose of this study is to confirm the efficacy and safety of selumetinib…
EUCTR2013-001676-38-HU · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2013-001676-38-HU |
|---|---|
| Public title | The purpose of this study is to confirm the efficacy and safety of selumetinib in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel |
| Scientific title | A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell… |
| Primary sponsor | AstraZeneca AB |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| 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 | Russian Federation;United States;Portugal;Netherlands;Austria;Sweden;Brazil;Poland;Bulgaria;Chile;France;Argentina;Romania;Hungary;Ukraine;United… |
| Conditions | Locally Advanced or Metastatic Non Small Cell Lung Cancer stage IIIb - IV;Therapeutic area: Diseases [C] - Cancer [C04] |
| Interventions | Product Name: Selumetinib Product Code: AZD6244 blue 25 mg capsule Pharmaceutical Form: Capsule, hard INN or Proposed INN: selumetinib CAS Number: 943332-08-9 Current Sponsor code: AZD6244 Hydrogen Sulfate Other descriptive name: Modified… |
| Registration date | Jun 19, 2013 |
| Target size | 500 |
| Secondary IDs | D1532C00079 |
| 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: