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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01000896

Enrollment

Registered

2009-10-23

Start date

2010-01-31

Completion date

2011-03-31

Last updated

2010-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGpaclitaxel

intravenous, 3 weeks

DRUGAZD0530

film coated tablet, PO, daily

DRUGCarboplatin

intravenous, 3 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026