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Phase I Study in Patients With Solid Tumours

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00496028
First received: July 3, 2007
Last updated: September 21, 2010
Last verified: September 2010

July 3, 2007
September 21, 2010
March 2007
January 2010   (final data collection date for primary outcome measure)
To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans. [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans. [ Time Frame: Assessed at each visit ]
Complete list of historical versions of study NCT00496028 on ClinicalTrials.gov Archive Site
  • To determine the Maximum Tolerated Dose of AZD0530 when administered in combination with carboplatin and/or paclitaxel by assessment of safety and tolerability data generated for each treatment arm. [ Time Frame: Assessed at each visit ] [ Designated as safety issue: Yes ]
  • To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers. [ Time Frame: Assessment at end of study ] [ Designated as safety issue: No ]
  • To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters. [ Time Frame: Predetermined timepoints after dose administration ] [ Designated as safety issue: No ]
  • To determine the Maximum Tolerated Dose of AZD0530 when administered in combination with carboplatin and/or paclitaxel by assessment of safety and tolerability data generated for each treatment arm. [ Time Frame: Assessed at each visit ]
  • To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers. [ Time Frame: Assessment at end of study ]
  • To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters. [ Time Frame: Predetermined timepoints after dose administration ]
Not Provided
Not Provided
 
Phase I Study in Patients With Solid Tumours
A Phase I, Open-label Study to Assess the Safety and Tolerability of AZD0530 in Combination With Carboplatin and/or Paclitaxel Chemotherapy in Patients With Solid Tumours

This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2 phases are part of a single study and described by this single protocol. Patients entered into the dose escalation phase will not be entered into the expansion phase. All subjects must be suitable for treatment with either carboplatin and/or paclitaxel.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • Drug: AZD0530
    oral tablet
  • Drug: Carboplatin
    intravenous infusion
  • Drug: Paclitaxel
    intravenous infusion
  • Experimental: 1
    AZD0530 + Paclitaxel
    Interventions:
    • Drug: AZD0530
    • Drug: Paclitaxel
  • Experimental: 2
    AZD0530 + Carboplatin
    Interventions:
    • Drug: AZD0530
    • Drug: Carboplatin
  • Experimental: 3
    AZD0530 + Carboplatin + Paclitaxel
    Interventions:
    • Drug: AZD0530
    • Drug: Carboplatin
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
March 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Life expectancy > 12 weeks
  • Women defined as post-menopausal
  • Male or female patients with locally advanced or metastatic cancer suitable for treatment with carboplatin and/or paclitaxel

Exclusion Criteria:

  • Inadequate bone marrow reserve
  • Inadequate live function, renal function or low haemoglobin
  • Unresolved toxicity from anti-cancer therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Netherlands,   Norway,   United Kingdom
 
NCT00496028
D8180C00023, AZD0530 study 23
Yes
Mary Stuart, MD - Medical Science Director EPT1, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Principal Investigator: Steinar Aamdal, MD Radium Hospital, Norway
Study Director: Mary Stuart, MD AstraZeneca
AstraZeneca
September 2010

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