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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

Thank you

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 SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteAlbany, New York  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas