Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer, Non Small Cell Lung Cancer, Epithelial Ovarian Cancer

Intervention / Treatment
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* Drug: AZD0530
* Drug: Carboplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD0530 + carboplatin and paclitaxel<br>AZD0530 in combination with carboplatin and paclitaxel | Drug: AZD0530<br>* film coated tablet, PO, daily<br>Drug: Carboplatin<br>* intravenous, 3 weeks<br>* Other names: Paraplatin;Drug: paclitaxel<br>* intravenous, 3 weeks<br>* Other names: Taxol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, general examination, HRCT, SpO2, ECG |  | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, cancer, solid tumors, advanced solid malignancies, NSCLC, epithelial ovarian cancer, dose escalation, combination treatment, src inhibitor, Japanese