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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


Phase 1
25 Years
N/A
Open (Enrolling)
Both
Cancer, Advanced Solid Malignancies

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

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).

Outcome 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.

Safety Issue:

Yes

Principal Investigator

Fabrice André, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut de cancérologie Gustave Roussy

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

D2610C00001

NCT ID:

NCT00979134

Start Date:

October 2009

Completion Date:

October 2014

Related Keywords:

  • Cancer
  • Advanced Solid Malignancies
  • Cancer
  • Tumour
  • Advanced Solid Malignancies
  • FGFR
  • Squamous NSCLC
  • Gastric adenocarcinoma
  • Neoplasms

Name

Location
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Albany, New York  
Research Site Allentown, Pennsylvania  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas