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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01000896
• Other study ID #: D8180C00020
• Status: Withdrawn
• Phase: Phase 1
• First received: October 14, 2009
• Last updated: February 3, 2010
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 27
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Non-Small-Cell Lung
• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Non Small Cell Lung Cancer
• Ovarian Neoplasms

Intervention

Drug:
• AZD0530
film coated tablet, PO, daily
• Carboplatin
intravenous, 3 weeks
• paclitaxel
intravenous, 3 weeks

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka
Japan	Research Site	Matsuyama	Ehime

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	Yes