A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors
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ClinicalTrials.gov Identifier: NCT00502567 |
Recruitment Status :
Completed
First Posted : July 17, 2007
Last Update Posted : July 27, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumor | Drug: AZD2171 Drug: FOLFOX Drug: Pemetrexed Drug: Irinotecan (administered with & without Cetuximab) Drug: Docetaxel | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | June 2011 |
- Drug: AZD2171
oral tablet once dailyOther Names:
- cediranib
- RECENTIN™.
- Drug: FOLFOX
intravenous infusionOther Name: 5-Fluorouracil, Leucovorin and Oxaliplatin
- Drug: Pemetrexed
intravenous infusionOther Names:
- Alimta®
- Pemetrexed disodium
- Drug: Irinotecan (administered with & without Cetuximab)
intravenous injectionOther Names:
- Campto®
- Camptosar®
- irinotecan hydrochloride
- Drug: Docetaxel
intravenous infusionOther Name: Taxotere®
- Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel [ Time Frame: After 5 weeks of treatment ]
- Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate. [ Time Frame: Assessed at each visit ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
- measurable lesion by CT or other techniques according to RECIST
Exclusion Criteria:
- Inadequate bone marrow reserve
- history of poorly controlled hypertension

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502567
United States, Michigan | |
Research Site | |
Ann Arbor, Michigan, United States | |
Research Site | |
Detroit, Michigan, United States | |
United States, Tennessee | |
Research Site | |
Nashville, Tennessee, United States |
Study Director: | Jane Robertson | AstraZeneca | |
Study Chair: | Bijoyesh Mookerjee, MD | AstraZeneca | |
Principal Investigator: | Patricia LoRusso, DO | Wayne State University |
Responsible Party: | Medical Science Director, AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00502567 |
Other Study ID Numbers: |
D8480C00008 |
First Posted: | July 17, 2007 Key Record Dates |
Last Update Posted: | July 27, 2011 |
Last Verified: | July 2011 |
advanced solid tumors AZD2171 Phase I |
Neoplasms Leucovorin Docetaxel Fluorouracil Oxaliplatin Irinotecan Pemetrexed Cetuximab Cediranib Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites |
Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Folic Acid Antagonists |