AZD8330 First Time in Man in Patients With Advanced Malignancies

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00454090
First received: March 27, 2007
Last updated: August 23, 2011
Last verified: August 2011

March 27, 2007
August 23, 2011
March 2007
October 2010   (final data collection date for primary outcome measure)
  • To assess safety and tolerability of AZD8330 in patient with advanced malignancies.
  • Outcome variables: Adverse Events, Clinical Chemistry, Haematology, Urinalysis, Vital signs, MUGA scans/echocardiography, ECGs, Ophthalmologic examination, O2 saturation
Same as current
Complete list of historical versions of study NCT00454090 on ClinicalTrials.gov Archive Site
  • To determine the PK of AZD8330.
  • To investigate possible PD/PK relationships
  • To investigate effect of AZD8330 on pERK in PBMCs
  • To determine the PK of AZD8330.
  • To investigate possible PD/PK relationships
  • To investigate effect of AZD8330 on pERK in PBMCs
  • Part B only: to investigate effect of AZD8330 on Ki67 and pERK in pre- and post- dose matched paired tumour biopsy
Not Provided
Not Provided
 
AZD8330 First Time in Man in Patients With Advanced Malignancies
A Phase I, Open-Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD8330 in Patients With Advanced Malignancies

The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: AZD8330
oral tablet
Other Name: ARRY-424704
Not Provided
Cohen RB, Aamdal S, Nyakas M, Cavallin M, Green D, Learoyd M, Smith I, Kurzrock R. A phase I dose-finding, safety and tolerability study of AZD8330 in patients with advanced malignancies. Eur J Cancer. 2013 May;49(7):1521-9. doi: 10.1016/j.ejca.2013.01.013. Epub 2013 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
March 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cancer which is refractory to standard therapies, or no therapies exist;

Exclusion Criteria:

  • Participated in radiotherapy, biological or chemotherapy within 21 days prior to study start;
  • Hasn't participated in investigation drug study within 30 days;
  • Brain metastases/spinal cord compression unless treated and stable,
  • Off steroids/anticonvulsants.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Norway
 
NCT00454090
D1536C00001
Not Provided
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Emerging Oncology Medical Science Director, MD AstraZeneca
AstraZeneca
August 2011

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