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

September 16, 2009
July 3, 2014
October 2009
February 2014   (final data collection date for primary outcome measure)
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 ]
  • To investigate the safety and tolerability of AZD4547 when given orally to patients with advanced solid malignancies and define the maximum tolerated dose (MTD). [ Time Frame: Safety Blood samples weekly throughout dosing. Physical Examination every 3 weeks. ECG and vital signs at least every 3 weeks. ] [ Designated as safety issue: Yes ]
  • To investigate the safety and tolerability of AZD4547 when given orally to patients with advanced solid malignancies and define the maximum tolerated dose (MTD). [ Time Frame: Ophthalmology at baseline and 3 weeks after start of BD dosing. MUGA / Echocardiogram at baseline, 3 weeks after start of BD dosing, and then every 3 months. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00979134 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after multiple dosing when given orally. [ Time Frame: PK samples out to 96 hours after single dose. Staeady State PK profile 3 weeks after 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 v1.1. [ Time Frame: Baseline assessment, then assessment every 6 weeks after start of treatment. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Advanced Solid Malignancies
  • Drug: AZD4547
    Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
  • Drug: AZD4547
    Patients start at a dose of 80 mg twice daily, with no washout
  • Drug: AZD4547
    Single dose is followed by washout 5-10 days before multiple dose
  • 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)
    Intervention: Drug: AZD4547
  • Experimental: Part B
    Dose expansion phase, at the RD defined in Part A
    Intervention: Drug: AZD4547
  • Experimental: Part C
    Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A
    Intervention: Drug: AZD4547
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
979
December 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT00979134
D2610C00001
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Fabrice André, Dr Institut de cancérologie Gustave Roussy
Study Director: Donal Landers, Dr AstraZeneca
AstraZeneca
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP