Clinical Trial VICCPHI1144
Title
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Patients with Advanced Solid Malignancies
Principal Investigator(s)
Details
- Protocol No. VICCPHI1144
- Open Date: 11/16/2011
- Staging: Phase I
- Age Group: Adults
- Scope: National
- Objective: To investigate the safety and tolerability of AZD4547 when given orally to patients with advanced solid malignancies and define the Maximum Tolerated Dose (MTD) and/or a continuous, tolerable Recommended Dose (RD).
- Disease Sites: Phase I
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: AZD4547
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT00979134
- Secondary Protocol No: D2610C00001
Description
Patients are being asked to take part in this research study because they have cancer. Normally, cells in the body divide and grow in an orderly way. But in cancer important substances that help control cell growth behave abnormally. This leads to faster cell growth and uncontrolled multiplication. In this study we are looking at a certain set of these substances, which change in a way that causes the cancer to grow. This study will test if the study drug AZD4547 can stop these substances working together and thus stop patients' cancer from growing. The purpose of this study is to look at the safety and tolerability of AZD4547 and to see if it is effective in treating these types of cancer. This study will also measure levels of the study drug in the blood and to see how the body accepts the study drug. The study drug AZD4547 is a new investigational drug. That means it is not approved by the Food and Drug Administration (FDA) to treat people with this medical condition. Between 15 to 20 people from the United States and Europe will take part in this study. About 5 people at Vanderbilt will take part in the study.
Eligibility
| Ages Eligible for Study: | 25 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• Minimum life expectancy of 12 weeks
• The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
• In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
• Expansion, 5 groups of advanced cancer
• Solid tumours,FGFR1 and/or FGFR2 gene amplified
• Squamous NSCLC, FGFR1 gene low & high amplified
• Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low & high amplified
• Aged at least 25 years
Exclusion Criteria:
• Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
• An inability to be able to take the study medication
• A bad reaction to AZD4547 or any drugs similar to it in structure or class.
Learn More
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