Back to resultsStudy to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel
Primary Purpose
Cancer, Non Small Cell Lung Cancer, Epithelial Ovarian Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
AZD0530
Carboplatin
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring Phase I, cancer, solid tumors, advanced solid malignancies, NSCLC, epithelial ovarian cancer, dose escalation, combination treatment, src inhibitor, Japanese
Eligibility Criteria
Inclusion Criteria:
- Japanese patients with non small cell lung cancer or epithelial ovarian cancer
- Must be suitable for treatment with carboplatin and paclitaxel
- Relatively good overall health other than cancer
Exclusion Criteria:
- Poor bone marrow function (not producing enough blood cells).
- Poor liver or kidney function.
- Patients unable to discontinue drugs known to be potent inhibitors or inducers of CYP3A4 within 2 weeks prior to registration
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AZD0530 + carboplatin and paclitaxel
Arm Description
AZD0530 in combination with carboplatin and paclitaxel
Outcomes
Primary Outcome Measures
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, general examination, HRCT, SpO2, ECG
Secondary Outcome Measures
Assessment of the pharmacokinetics of AZD0530 (Cssmax, Cssmin, tmax, AUCss0-24, CL/F), its N-desmethyl metabolite M594347 (Cssmax, Cssmin, tmax, AUCss0-24), and carboplatin / paclitaxel (Cmax, AUC, AUC0-t, t1/2, CL and Vss)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01000896
Brief Title
Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel
Official Title
A Phase I, Open-Label, Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD0530 in Combination With Carboplatin and Paclitaxel Chemotherapy in Japanese Patients With Advanced Solid Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Withdrawn
Why Stopped
AstraZeneca has discontinued the development of AZD0530. No new AstraZeneca-sponsored clinical studies will be initiated..
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Non Small Cell Lung Cancer, Epithelial Ovarian Cancer
Keywords
Phase I, cancer, solid tumors, advanced solid malignancies, NSCLC, epithelial ovarian cancer, dose escalation, combination treatment, src inhibitor, Japanese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AZD0530 + carboplatin and paclitaxel
Arm Type
Experimental
Arm Description
AZD0530 in combination with carboplatin and paclitaxel
Intervention Type
Drug
Intervention Name(s)
AZD0530
Intervention Description
film coated tablet, PO, daily
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
intravenous, 3 weeks
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
intravenous, 3 weeks
Primary Outcome Measure Information:
Title
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, general examination, HRCT, SpO2, ECG
Time Frame
Laboratory assessment prior to chemotherapy administration in all treatment cycles and on days 2, 8 and 15 in cycle 1. General exam, SpO2 and ECG prior to chemotherapy administration in all treatment cycles. HRCT scans performed days 21, 42, 70-98.
Secondary Outcome Measure Information:
Title
Assessment of the pharmacokinetics of AZD0530 (Cssmax, Cssmin, tmax, AUCss0-24, CL/F), its N-desmethyl metabolite M594347 (Cssmax, Cssmin, tmax, AUCss0-24), and carboplatin / paclitaxel (Cmax, AUC, AUC0-t, t1/2, CL and Vss)
Time Frame
Schedule of PK assessment1. AZD0530/N-desmethyl metabolite M594347Cycle1-day21 -Cycle2-day2; 11point2. carboplatinCycle1-day1 ~ day2; 8 pointCycle2-day1 ~ day2; 8 point3. paclitaxelCycle1-day1 ~day2; 9 pointCycle2-day1 ~ day2; 9 point
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Japanese patients with non small cell lung cancer or epithelial ovarian cancer
Must be suitable for treatment with carboplatin and paclitaxel
Relatively good overall health other than cancer
Exclusion Criteria:
Poor bone marrow function (not producing enough blood cells).
Poor liver or kidney function.
Patients unable to discontinue drugs known to be potent inhibitors or inducers of CYP3A4 within 2 weeks prior to registration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Stuart
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Takashi Seto, MD, PhD
Organizational Affiliation
National Hospital Organisation Kyushu Cancer Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naoyuki Nogami, MD
Organizational Affiliation
National Hospital Organisation Shikoku Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
12. IPD Sharing Statement
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Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel
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