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OpenTrials
Completed

NCT Number: NCT00496028

Phase I Study 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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD0530

Drug

oral tablet

carboplatin

Drug

intravenous infusion

paclitaxel

Drug

intravenous infusion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 4, 2007
Registry last updated
Sep 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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