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

AstraZeneca104 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Advanced Solid Tumor

Interventions

AZD2171DRUG

oral tablet once daily

FOLFOXDRUG

intravenous infusion

PemetrexedDRUG

intravenous infusion

Irinotecan (administered with & without Cetuximab)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Research Site

Ann Arbor, Michigan, United States

Research Site

Detroit, Michigan, United States

Research Site

Nashville, Tennessee, United States

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.

Time frame: Assessed at each visit

Data from ClinicalTrials.gov

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