Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma

NCT ID: NCT00423332

Last Updated: 2017-02-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2016-10-31

Brief Summary

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Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Cediranib placebo

Group Type PLACEBO_COMPARATOR

Cediranib Placebo

Intervention Type DRUG

oral tablet

2

Cediranib

Group Type EXPERIMENTAL

Cediranib

Intervention Type DRUG

45 mg oral tablet

Interventions

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Cediranib

45 mg oral tablet

Intervention Type DRUG

Cediranib Placebo

oral tablet

Intervention Type DRUG

Other Intervention Names

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AZD2171 RECENTIN™

Eligibility Criteria

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Inclusion Criteria

* Confirmation of metastatic or recurrent renal cell carcinoma

Exclusion Criteria

* Certain types of previous anti-cancer therapy for Renal Cell Carcinoma
* Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes
* Patients with a history of poorly controlled high blood pressure
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Robertson

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Groningen, , Netherlands

Site Status

Research Site

Leiden, , Netherlands

Site Status

Research Site

Nijmegen, , Netherlands

Site Status

Research Site

Birmingham, , United Kingdom

Site Status

Research Site

London, , United Kingdom

Site Status

Research Site

Manchester, , United Kingdom

Site Status

Research Site

Northwood, , United Kingdom

Site Status

Research Site

Oxford, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

References

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Mulders P, Hawkins R, Nathan P, de Jong I, Osanto S, Porfiri E, Protheroe A, van Herpen CM, Mookerjee B, Pike L, Jurgensmeier JM, Gore ME. Cediranib monotherapy in patients with advanced renal cell carcinoma: results of a randomised phase II study. Eur J Cancer. 2012 Mar;48(4):527-37. doi: 10.1016/j.ejca.2011.12.022. Epub 2012 Jan 28.

Reference Type DERIVED
PMID: 22285180 (View on PubMed)

Related Links

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Other Identifiers

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EudraCT no. 2006-002455-33

Identifier Type: -

Identifier Source: secondary_id

D8480C00030

Identifier Type: -

Identifier Source: org_study_id

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