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Phase I Study in Patients With Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496028
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : September 22, 2010
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: AZD0530 Drug: Carboplatin Drug: Paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
AZD0530 + Paclitaxel
Drug: AZD0530
oral tablet

Drug: Paclitaxel
intravenous infusion

Experimental: 2
AZD0530 + Carboplatin
Drug: AZD0530
oral tablet

Drug: Carboplatin
intravenous infusion

Experimental: 3
AZD0530 + Carboplatin + Paclitaxel
Drug: AZD0530
oral tablet

Drug: Carboplatin
intravenous infusion

Drug: Paclitaxel
intravenous infusion

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00496028

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Research Site
Paris, France
Research Site
Pierre Benite Cedex, France
Research Site
Amsterdam, Netherlands
Research Site
Groningen, Netherlands
Research Site
Oslo, Norway
United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Sutton, United Kingdom
Sponsors and Collaborators
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Principal Investigator: Steinar Aamdal, MD Radium Hospital, Norway
Study Director: Mary Stuart, MD AstraZeneca

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Responsible Party: Mary Stuart, MD - Medical Science Director EPT1, AstraZeneca Pharmaceuticals Identifier: NCT00496028     History of Changes
Other Study ID Numbers: D8180C00023
AZD0530 study 23
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: September 22, 2010
Last Verified: September 2010

Keywords provided by AstraZeneca:
Solid tumors
locally advanced or Metastatic Cancer suitable for treatment with carboplatin and/or paclitaxel

Additional relevant MeSH terms:
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Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors