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CompletedNCT00264004Updated Aug 29, 2012Results posted

Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours

A Phase 2 interventional study of AZD2171 in Tumors, sponsored by AstraZeneca. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-29.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.

02

Conditions studied

  • Tumors

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Keywords

  • Advanced Solid Tumours
  • phase II
  • Hypertension
  • RECENTIN
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 119 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.

Exclusion criteria

Exclusion Criteria:

  • Prior treatment with a VEGF inhibitor
  • Poorly controlled hypertension
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
119 participants (actual)

Study arms

  • Experimental
    1

    30 mg AZD2171

    Drug: AZD2171

  • Experimental
    2

    45 mg AZD2171

    Drug: AZD2171

Interventions

  • DrugAZD2171

    30 mg \& 45 mg oral tablet

    Also known as: Cediranib, RECENTIN™

06

What researchers measure

Primary outcomes

  1. Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171

    Time frame: 12 week treatment period

  2. Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171

    Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)

    Time frame: 12 week treatment period

Secondary outcomes

  1. Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171

    Time frame: First 6 weeks of 12 week treatment period

  2. Objective Response Rate

    Number of patients with complete or partial response (CR/PR), based on RECIST

    Time frame: 12 week treatment period

  3. Best Percentage Change in Tumour Size

    Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.

    Time frame: Randomisation until end of treatment period

07

Results

Posted Aug 29, 2012

Participant flow

Participant flow — Overall Study
MilestoneAZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HT
Started30323034
Completed13211619
Not completed17111415
Withdrew: Adverse event2364
Withdrew: Withdrawal by subject0122
Withdrew: Other2203
Withdrew: Development study specific disc. crit.1010
Withdrew: Cond. under inv. worsened9534
Withdrew: Not treated3022

Outcome measures

PrimaryProportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171
Time frame:
12 week treatment period
Reported as:
Number · Participants
Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171
ParticipantsAZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HT
Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD217112192024
PrimaryProportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171

Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)

Time frame:
12 week treatment period
Reported as:
Median · Poportion of Planned Dose
Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171
Poportion of Planned DoseAZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HT
Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD21710.89 (0.62 to 1.00)0.88 (0.76 to 0.98)0.74 (0.58 to .91)0.79 (0.64 to 0.87)
SecondaryProportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171
Time frame:
First 6 weeks of 12 week treatment period
Reported as:
Number · Participants
Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171
ParticipantsAZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HT
Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171991619
SecondaryObjective Response Rate

Number of patients with complete or partial response (CR/PR), based on RECIST

Time frame:
12 week treatment period
Reported as:
Number · Participants
Objective Response Rate
ParticipantsAZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HT
Objective Response Rate1323
SecondaryBest Percentage Change in Tumour Size

Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.

Time frame:
Randomisation until end of treatment period
Reported as:
Geometric mean · percentage of tumor size
Best Percentage Change in Tumour Size
percentage of tumor sizeAZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HT
Best Percentage Change in Tumour Size-1.12 (-8.96 to 7.38)-10.81 (-23.99 to 4.65)-11.78 (-22.53 to 0.46)-13.13 (-20.39 to -5.21)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AZD2171 30 mg Anti HT—19/28 (67.9%)31/28 (110.7%)
AZD2171 30 mg No Anti HT—20/31 (64.5%)34/31 (109.7%)
AZD2171 45 mg Anti HT—10/26 (38.5%)27/26 (103.8%)
AZD2171 45 mg No Anti HT—10/34 (29.4%)26/34 (76.5%)
Most frequent serious events
Showing 10 of 51
Most frequent serious events
EventAZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HT
HypertensionVascular disorders3/285/314/260/34
AnorexiaMetabolism and nutrition disorders0/282/310/263/34
Abdominal PainGastrointestinal disorders2/281/312/260/34
AscitesGastrointestinal disorders0/281/312/260/34
DiarrhoeaGastrointestinal disorders1/281/312/261/34
FatigueGeneral disorders1/281/312/262/34
Back PainMusculoskeletal and connective tissue disorders0/281/312/260/34
PyrexiaGeneral disorders2/280/311/261/34
DysphagiaGastrointestinal disorders0/282/310/260/34
VomitingGastrointestinal disorders1/282/311/261/34
Most frequent other events
Showing 10 of 93
Most frequent other events
EventAZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HT
DiarrhoeaGastrointestinal disorders23/2824/3123/2620/34
HypertensionVascular disorders21/2825/3115/2619/34
FatigueGeneral disorders19/2821/3119/2618/34
DysphoniaRespiratory, thoracic and mediastinal disorders16/2818/3115/2619/34
NauseaGastrointestinal disorders16/2815/318/268/34
AnorexiaMetabolism and nutrition disorders14/2812/318/2612/34
StomatitisGastrointestinal disorders10/2813/317/2612/34
ConstipationGastrointestinal disorders9/288/315/265/34
VomitingGastrointestinal disorders9/288/318/265/34
Palmar-Plantar Erythrodysaesthesia SyndromeSkin and subcutaneous tissue disorders5/289/315/2610/34

Baseline characteristics

Age Continuous
Age Continuous(Years)AZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HTTotal
Age58.1 ± 9.352.7 ± 12.956.4 ± 11.053.5 ± 11.755.175 ± 11.225
Sex: Female, Male
Sex: Female, Male(Participants)AZD2171 30 mg Anti HTAZD2171 30 mg No Anti HTAZD2171 45 mg Anti HTAZD2171 45 mg No Anti HTTotal
Female1216132566
Male181617960
08

Study locations

6 sites
  • Research Site
    Freiburg, Germany
  • Research Site
    Hamburg, Germany
  • Research Site
    Amsterdam, Netherlands
  • Research Site
    Nijmegen, Netherlands
  • Research Site
    Utrecht, Netherlands
  • Research Site
    Surrey, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00264004
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 12, 2005
Start date
Nov 2005
Primary completion
Jan 2007
Completion
Apr 2011
Results posted
Aug 29, 2012
Last update
Aug 29, 2012

Study contacts

Jane Robertson, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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