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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01974752
Other study ID # D1344C00001
Secondary ID
Status Completed
Phase Phase 3
First received October 10, 2013
Last updated January 4, 2017
Start date April 2014
Est. completion date October 2016

Study information

Verified date January 2017
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority France: *National Agency for the Safety of Medicine and Health Products.*Belgium: Federal Agency for Medicinal Products and Health ProductsNetherlands: Medicines Evaluation Board (MEB)Israel: *Regulations of Ministry of Health.*Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Selumetinib therapy in patients with metastatic uveal melanoma.


Description:

A randomised double-blind study to assess the efficacy of selumetinib (AZD6244, Hyd-Sulfate) in combination with Dacarbazine compared with placebo in combination with Dacarbazine as first systemic therapy in patients with metastatic uveal melanoma (SUMIT)


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
75mg selumetinib
selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
placebo
placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
Dacarbazine
dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily.

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Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Finland,  France,  Germany,  Israel,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1. Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 No
Secondary Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR ORR at Week 6 using BICR according to RECIST 1.1 From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 No
Secondary Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR Percent change in tumour size at Week 6 using BICR according to RECIST 1.1 From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 No
Secondary Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine Overall Survival From Randomization, up until death assessed up to 15th May 2015 No
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