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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00539331
• Other study ID #: D8480C00040
• Status: Terminated
• Phase: Phase 1
• First received: October 2, 2007
• Last updated: May 30, 2011
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyJapan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• AZD2171
oral tablet
• Paclitaxel
intravenous infusion
• Carboplatin
intravenous injection

Locations

Country	Name	City	State
Japan	Research Site	Osaka
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer		Assessed at each visit during Part A	No
Primary	PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS)		time to progression	No
Secondary	PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel		Assessed at each visit during Part A	No
Secondary	PART B : To determine the efficacy of AZD2171 by assessment of overall response rate, change in tumour size and overall survival		time to death	No