Phase I Study in Patients With Solid Tumours

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: AZD0530; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT00496028
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-21
• Last Update Posted: 2010-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

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Exclusion Criteria

• Inadequate bone marrow reserve
• Inadequate live function, renal function or low haemoglobin
• Unresolved toxicity from anti-cancer therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD0530	AZD0530 + Paclitaxel
1	Paclitaxel	AZD0530 + Paclitaxel
2	AZD0530	AZD0530 + Carboplatin
2	Carboplatin	AZD0530 + Carboplatin
3	AZD0530	AZD0530 + Carboplatin + Paclitaxel
3	Carboplatin	AZD0530 + Carboplatin + Paclitaxel
3	Paclitaxel	AZD0530 + Carboplatin + Paclitaxel

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sutton, United Kingdom