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

NCT00502567 | Completed Phase 1

• 1 other identifier: D8480C00008
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

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).

Conditions

Advanced Solid Tumor

Keywords

advanced solid tumors; AZD2171; Phase I

Outcome Measures

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

  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.

  Assessed at each visit

Interventions

AZD2171 DRUG

oral tablet once daily

Also known as: cediranib, RECENTIN™.

FOLFOX DRUG

intravenous infusion

Also known as: 5-Fluorouracil, Leucovorin and Oxaliplatin

Pemetrexed DRUG

intravenous infusion

Also known as: Alimta®, Pemetrexed disodium

Irinotecan (administered with & without Cetuximab) DRUG

intravenous injection

Also known as: Campto®, Camptosar®, irinotecan hydrochloride

Docetaxel DRUG

intravenous infusion

Also known as: Taxotere®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inadequate bone marrow reserve
• history of poorly controlled hypertension

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Ann Arbor, Michigan, United States

Location

Research Site

Detroit, Michigan, United States

Location

Research Site

Nashville, Tennessee, United States

Location

MeSH Terms

Interventions

cediranib; Folfox protocol; Fluorouracil; Leucovorin; Oxaliplatin; Pemetrexed; Irinotecan; Cetuximab; Docetaxel

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Camptothecin; Alkaloids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Jane Robertson

  AstraZeneca

  STUDY DIRECTOR

• Bijoyesh Mookerjee, MD

  AstraZeneca

  STUDY CHAIR

• Patricia LoRusso, DO

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 17, 2007
• Study Start: January 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2011
• Last Updated: July 27, 2011

Record last verified: 2011-07

Locations

US (3)