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Completed

NCT Number: NCT00502567

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

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).

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2171

Drug

oral tablet once daily

Other names: cediranib, RECENTIN™.

FOLFOX

Drug

intravenous infusion

Other names: 5-Fluorouracil, Leucovorin and Oxaliplatin

Pemetrexed

Drug

intravenous infusion

Other names: Alimta®, Pemetrexed disodium

Irinotecan (administered with & without Cetuximab)

Drug

intravenous injection

Other names: Campto®, Camptosar®, irinotecan hydrochloride

docetaxel

Drug

intravenous infusion

Other names: Taxotere®

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2011
First posted
Jul 17, 2007
Registry last updated
Jul 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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