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
  Purpose

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 Intervention Phase
Neoplasms
Drug: AZD0530
Drug: Carboplatin
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 148
Study Start Date: March 2007
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496028

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

No publications provided

Responsible Party: Mary Stuart, MD - Medical Science Director EPT1, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00496028     History of Changes
Other Study ID Numbers: D8180C00023, AZD0530 study 23
Study First Received: July 3, 2007
Last Updated: September 21, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Norway: Norwegian Medicines Agency
Netherlands: Dutch Health Care Inspectorate
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Neoplasms
Saracatinib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014