Phase I Study in Patients With Solid Tumours - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00496028

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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

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 ]

Estimated Enrollment:	174
Study Start Date:	March 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD0530 + Paclitaxel	Drug: AZD0530 oral tablet Drug: Paclitaxel intravenous infusion
2: Experimental AZD0530 + Carboplatin	Drug: AZD0530 oral tablet Drug: Carboplatin intravenous infusion
3: Experimental 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

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

Contacts

Contact: AstraZeneca Clinical Study Information

AZD0530ClinicalTrialsMailbox@astrazeneca.com

Locations

France
Research Site	Recruiting
Paris, France
Research Site	Recruiting
Pierre Benite Cedex, France
Netherlands
Research Site	Recruiting
Amsterdam, Netherlands
Research Site	Recruiting
Groningen, Netherlands
Norway
Research Site	Recruiting
Oslo, Norway
United Kingdom
Research Site	Recruiting
Sutton, United Kingdom
Research Site	Recruiting
Glasgow, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Steinar Aamdal, MD	Radium Hospital, Norway
Study Director:	Mary Stuart, MD	AstraZeneca

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Mary Stuart, MD - Medical Science Director EPT1 )
Study ID Numbers:	D8180C00023, AZD0530 study 23
Study First Received:	July 3, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00496028
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Norway: Norwegian Medicines Agency; Netherlands: Dutch Health Care Inspectorate; France: Afssaps - French Health Products Safety Agency

Keywords provided by AstraZeneca:

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

Study placed in the following topic categories:

Paclitaxel
Neoplasm Metastasis
Carboplatin

Additional relevant MeSH terms:

Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009