Phase 2
Completed N=126
Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours
Source: ClinicalTrials.gov NCT00264004 ↗Enrolled (actual)
126
Serious AEs
49.6%
Results posted
Aug 2012
Primary outcomePrimary: Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171 — 12; 19; 20; 24 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171 |
12; 19; 20; 24 | — |
| PRIMARY Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171 |
0.89; 0.88; 0.74; 0.79 | — |
| SECONDARY Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171 |
9; 9; 16; 19 | — |
| SECONDARY Objective Response Rate |
1; 3; 2; 3 | — |
| SECONDARY Best Percentage Change in Tumour Size |
-1.12; -10.81; -11.78; -13.13 | — |
Eligibility Criteria
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
- Prior treatment with a VEGF inhibitor
- Poorly controlled hypertension
Data sourced from ClinicalTrials.gov (NCT00264004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.