Phase I Study in Patients With Solid Tumours

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00496028

Enrollment

148

Registered

2007-07-04

Start date

2007-03-31

Completion date

2010-03-31

Last updated

2010-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Solid tumors, locally advanced or Metastatic Cancer suitable for treatment with carboplatin and/or paclitaxel

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.

Interventions

DRUGAZD0530

oral tablet

DRUGCarboplatin

intravenous infusion

DRUGPaclitaxel

intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France, Netherlands, Norway, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026