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

AstraZeneca3 sites in 1 country104 target enrollmentStarted: January 1, 2005Last updated: July 27, 2011

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: AstraZeneca
Enrollment: 104
Locations: 3
Primary Endpoint: 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

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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).

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Investigators

Sponsor

AstraZeneca

Sponsor Class

Industry

Study Sites (3)

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