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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00502567
Enrollment
104
Registered
2007-07-17
Start date
2005-01-31
Completion date
2011-06-30
Last updated
2011-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor

Keywords

advanced solid tumors, AZD2171, Phase I

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).

Interventions

DRUGAZD2171

oral tablet once daily

DRUGFOLFOX

intravenous infusion

DRUGPemetrexed

intravenous infusion

DRUGIrinotecan (administered with & without Cetuximab)

intravenous injection

DRUGDocetaxel

intravenous infusion

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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, DocetaxelAfter 5 weeks of treatment

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026