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NCT00502567 Clinical Trial

A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00502567
Other study ID # D8480C00008
Secondary ID
Status Completed
Phase Phase 1
First received July 16, 2007
Last updated July 26, 2011
Start date January 2005
Est. completion date June 2011

Study information
Verified date July 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date June 2011
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AZD2171
oral tablet once daily
• FOLFOX
intravenous infusion
• Pemetrexed
intravenous infusion
• Irinotecan (administered with & without Cetuximab)
intravenous injection
• Docetaxel
intravenous infusion

Locations
Country Name City State
United States Research Site Ann Arbor Michigan
United States Research Site Detroit Michigan
United States Research Site Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 After 5 weeks of treatment No
Secondary 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. Assessed at each visit No
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Recruiting NCT05443126 - A Study of EP0031 in Patients With Advanced RET-altered Malignancies Phase 1/Phase 2
Recruiting NCT05461287 - Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors Phase 1
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