Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00979134
First received: September 16, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.


Condition Intervention Phase
Cancer
Advanced Solid Malignancies
Drug: AZD4547
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 dose Recommended Dose (RD). [ Time Frame: Blood samples weekly during dosing. Physical Exam every 3 weeks. ECG & vital, minimum every 3 weeks. Ophthalmology at baseline, monthly for 3 months then every 8 weeks. MUGA/Echocardiogram at baseline, 3 weeks after start of dosing and every 3 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally. [ Time Frame: PK samples out to 96 hours after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing. ] [ Designated as safety issue: No ]
  • To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1 [ Time Frame: Baseline assessment, then assessment every 6 weeks after start of treatment. ] [ Designated as safety issue: No ]

Enrollment: 979
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A
Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD)
Drug: AZD4547
Single dose is followed by washout 5-10 days before multiple dose
Experimental: Part B
Dose expansion phase, at the RD defined in Part A
Drug: AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Experimental: Part C
Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A
Drug: AZD4547
Patients start at a dose of 80 mg twice daily, with no washout

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979134

  Show 27 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Fabrice André, Dr Institut de cancérologie Gustave Roussy
Study Director: Donal Landers, Dr AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00979134     History of Changes
Other Study ID Numbers: D2610C00001
Study First Received: September 16, 2009
Last Updated: July 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Italy: National Institute of Health
Spain: Spanish Agency of Medicines and Health Products

Keywords provided by AstraZeneca:
Cancer
Tumour
Advanced Solid Malignancies
FGFR
Squamous NSCLC
Gastric adenocarcinoma

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014