Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00501605
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

Single centre recruiting approximately 80 patients who are given a rising single, followed by multiple, ascending oral dose of AZD2171, assessing the safety and tolerability of AZD2171 in patients with solid tumors and metastatic liver disease.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor; Liver Metastases	Drug: AZD2171	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Single Centre 2-part Open Study to Assess the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients With Advanced Solid Malignant Tumors and Liver Metastases
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Apr 1, 2005
• Actual Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

1. primary objective is to evaluate the safety and tolerability of ascending single&multiple oral doses of AZD2171 by assessment of AEs,BP,HR,RR,ECG,clinical chemistry,haematology,urinalysis incl 24hr collection for protein&creatinine and physical exam. []

Secondary Outcome Measures

1. PK,assess the effects of AZD2171 on surrogate markets of activity and to make a preliminary assessment of anti-tumor activity by measurement of tumor response and time to progression []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Provision of written informed consent

• Male/female, 18 yr or over

• WHO status 0-2

• Refractory advanced solid tumor

Exclusion Criteria:

• Radiotherapy within 4 weeks of starting AZD2171 treatment

• Low haemoglobin level

• Low platelet or neutrophil counts

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Freiburg		Germany

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM, AstraZeneca
• Principal Investigator: J. Drevs, PD, Klinik fur.Internistische Onkologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00501605
• Other Study ID Numbers: D8480C00001
• First Posted: Jul 16, 2007
• Last Update Posted: Jan 21, 2011
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Phase I; AZD2171; advanced solid tumors
• Additional relevant MeSH terms: Neoplasms; Neoplasm Metastasis; Liver Neoplasms; Cediranib

Study Results

No Results Posted as of Jan 21, 2011