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| ID | Type | Description | Link |
|---|---|---|---|
| EuDract #2006-003505-55 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD2171 Monotherapy |
|
| 2 | Experimental | AZD2171 + AZD0530 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2171 | Drug | oral tablet multiple ascending doses 20, 30 or 45 mg |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Roberston | AstraZeneca | Study Director |
| Tanja Trarbach, MD | Universitatsklinikum der GHS Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Freiburg im Breisgau | Baden-Wurttemberg | Germany | |||
| Research Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D018281 | Cholangiocarcinoma |
| D003110 | Colonic Neoplasms |
| D013274 | Stomach Neoplasms |
| D002822 | Choriocarcinoma |
| D008113 | Liver Neoplasms |
| D054219 | Neoplasms, Plasma Cell |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C500926 | cediranib |
| C515233 | saracatinib |
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| AZD0530 | Drug | oral tablet multiple ascending doses 125 mg or 175 mg |
|
| assessed during study |
| Essen |
| Ruhr |
| Germany |
| Research Site | Herne | Ruhr | Germany |
| D012140 |
| Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |