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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00979134
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : June 26, 2015
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Advanced Solid Malignancies Drug: AZD4547 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 979 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00979134

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

Responsible Party: AstraZeneca Identifier: NCT00979134     History of Changes
Other Study ID Numbers: D2610C00001
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms: