Phase I Study in Patients With Solid Tumours

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496028
• Other study ID #: D8180C00023
• Secondary ID: AZD0530 study 23
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2007
• Last updated: September 21, 2010
• Start date: March 2007
• Est. completion date: March 2010

Study information

• Verified date: September 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyNorway: Norwegian Medicines AgencyNetherlands: Dutch Health Care InspectorateFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• AZD0530
oral tablet
• Carboplatin
intravenous infusion
• Paclitaxel
intravenous infusion

Locations

Country	Name	City	State
France	Research Site	Paris
France	Research Site	Pierre Benite Cedex
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Groningen
Norway	Research Site	Oslo
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

France,  Netherlands,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Assessed at each visit	No
Secondary	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.		Assessed at each visit	Yes
Secondary	To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers.		Assessment at end of study	No
Secondary	To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters.		Predetermined timepoints after dose administration	No