A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00502567
First received: July 16, 2007
Last updated: July 26, 2011
Last verified: July 2011
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Purpose
A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumor |
Drug: AZD2171 Drug: FOLFOX Drug: Pemetrexed Drug: Irinotecan (administered with & without Cetuximab) Drug: Docetaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Drug Information available for:
Irinotecan
Irinotecan hydrochloride
Docetaxel
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | January 2005 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: AZD2171
- cediranib
- RECENTIN™.
- Alimta®
- Pemetrexed disodium
- Campto®
- Camptosar®
- irinotecan hydrochloride
oral tablet once daily
Other Names:
Drug: FOLFOX
intravenous infusion
Other Name: 5-Fluorouracil, Leucovorin and Oxaliplatin
Drug: Pemetrexed
intravenous infusion
Other Names:
Drug: Irinotecan (administered with & without Cetuximab)
intravenous injection
Other Names:
Drug: Docetaxel
intravenous infusion
Other Name: Taxotere®
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502567
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502567
Locations
| 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 | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Jane Robertson | AstraZeneca | |
| Study Chair: | Bijoyesh Mookerjee, MD | AstraZeneca | |
| Principal Investigator: | Patricia LoRusso, DO | Wayne State University |
More Information
No publications provided
| Responsible Party: | Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00502567 History of Changes |
| Other Study ID Numbers: | D8480C00008 |
| Study First Received: | July 16, 2007 |
| Last Updated: | July 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
advanced solid tumors AZD2171 Phase I |
Additional relevant MeSH terms:
|
Irinotecan Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antineoplastic Agents, Phytogenic Enzyme Inhibitors |
Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Topoisomerase I Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on February 27, 2015