Phase I/II Study of AZD2171 in Combination With Paclitaxel/Carboplatin in Japanese Non-Small Cell Lung Cancer Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00539331

Purpose

The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study's Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III. As the design of Study 040 is similar to that of Study BR24, AstraZeneca has suspended recruitment into Study 040.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: AZD2171 Drug: Paclitaxel Drug: Carboplatin	Phase I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Cediranib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of Pac/Carb Alone and in Combination With AZD2171 and Pac/Carb

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer [ Time Frame: Assessed at each visit during Part A ] [ Designated as safety issue: No ]
PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS) [ Time Frame: time to progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel [ Time Frame: Assessed at each visit during Part A ] [ Designated as safety issue: No ]
PART B : To determine the efficacy of AZD2171 by assessment of overall response rate, change in tumour size and overall survival [ Time Frame: time to death ] [ Designated as safety issue: No ]

Estimated Enrollment:	148
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2010

Arms	Assigned Interventions
1: Placebo Comparator Paclitaxel/Carboplatin	Drug: Paclitaxel intravenous infusion Drug: Carboplatin intravenous injection
2: Experimental Paclitaxel/Carboplatin + AZD2171	Drug: AZD2171 oral tablet Drug: Paclitaxel intravenous infusion Drug: Carboplatin intravenous injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Having histologically or cytologically confirmed NSCLC
Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC
WHO performance status 0-1

Exclusion Criteria:

Untreated unstable brain or meningeal metastases
Patient with inappropriate laboratory tests values
Patient with poorly controlled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539331

Locations

Japan
Research Site
Tokyo, Japan
Research Site
Shizuoka, Japan
Research Site
Osaka, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Nick Botwood, MBBS MRCP MFPM	AstraZeneca
Principal Investigator:	Masahiro Fukuoka, MD	Sakai hospital Kinki University School of Medicine
Study Chair:	Eisei Shin, MD	AstraZeneca

More Information

Study ID Numbers:	D8480C00040
Study First Received:	October 2, 2007
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00539331
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency; Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:

Non-small Cell Lung Cancer
NSCLC
AZD2171
Paclitaxel/Carboplatin
Non-small Cell Lung Cancer (NSCLC)

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
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