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

Sponsor

AstraZeneca (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01000896

Collaborator

(none)

Enrollment

Locations

Arm

13.9

Duration (Months)

13.5

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Non Small Cell Lung Cancer Epithelial Ovarian Cancer	Drug: AZD0530 Drug: Carboplatin Drug: paclitaxel	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2010

Anticipated Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD0530 + carboplatin and paclitaxel AZD0530 in combination with carboplatin and paclitaxel	Drug: AZD0530 film coated tablet, PO, daily Drug: Carboplatin intravenous, 3 weeks Other Names: Paraplatin Drug: paclitaxel intravenous, 3 weeks Other Names: Taxol

Arm

Intervention/Treatment

Experimental: AZD0530 + carboplatin and paclitaxel

AZD0530 in combination with carboplatin and paclitaxel

Drug: AZD0530

film coated tablet, PO, daily

Drug: Carboplatin

intravenous, 3 weeks

Other Names:

Paraplatin

Drug: paclitaxel

intravenous, 3 weeks

Other Names:

Taxol

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Matsuyama	Ehime	Japan
2	Research Site	Fukuoka		Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Mary Stuart, AstraZeneca
Principal Investigator: Takashi Seto, MD, PhD, National Hospital Organisation Kyushu Cancer Centre
Principal Investigator: Naoyuki Nogami, MD, National Hospital Organisation Shikoku Cancer Centre