Phase I Study in Patients With Solid Tumours

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00496028

Collaborator

(none)

148

Enrollment

Locations

Arms

Duration (Months)

21.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: AZD0530 Drug: Carboplatin Drug: Paclitaxel	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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. [Assessed at each visit]

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. [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Paris	France
2	Research Site	Pierre Benite Cedex	France
3	Research Site	Amsterdam	Netherlands
4	Research Site	Groningen	Netherlands
5	Research Site	Oslo	Norway
6	Research Site	Glasgow	United Kingdom
7	Research Site	Sutton	United Kingdom