Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

Study Overview
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Brief Summary
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The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.

Official Title
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Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: AZD2171
* Drug: AZD0530


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written consent Cancer diagnosis & stage Patients for whom no standard therapy exists World Health Organization (WHO) performance status 0-2 One or more measurable lesions Exclusion Criteria: Prostate cancer Untreated unstable brain or meningeal metastases Specific laboratory ranges Pregnant or breast-feeding women Any evidence of severe or uncontrolled diseases Participation in other trials within 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD2171 Monotherapy | Drug: AZD2171<br>* oral tablet multiple ascending doses 20, 30 or 45 mg<br>* Other names: RECENTIN™;|
| Experimental: 2<br>AZD2171 + AZD0530 | Drug: AZD2171<br>* oral tablet multiple ascending doses 20, 30 or 45 mg<br>* Other names: RECENTIN™;Drug: AZD0530<br>* oral tablet multiple ascending doses 125 mg or 175 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam |  | assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530 |  | assessed at each visit | 
| Safety and efficacy |  | assessed at each visit | 
| Genetic variation of pathways targeted by AZD2171 and AZD0530 |  | assessed during study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal Cancer, Cancer, Tumour, Advanced Solid Tumour, Lung Cancer, Breast Cancer, Cholangiocarcinoma, Colon Cancer, Gastric Cancer, Choriocarcinoma, Liver Cancer, Myeloma, Ovarian Cancer, Pancreatic Cancer