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

This study has been withdrawn prior to enrollment.
(AstraZeneca has discontinued the development of AZD0530. No new AstraZeneca-sponsored clinical studies will be initiated..)
Information provided by:
AstraZeneca Identifier:
First received: October 14, 2009
Last updated: February 3, 2010
Last verified: February 2010
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 Intervention Phase
Non Small Cell Lung Cancer
Epithelial Ovarian Cancer
Drug: AZD0530
Drug: Carboplatin
Drug: paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

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) [ 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: January 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Paraplatin
Drug: paclitaxel
intravenous, 3 weeks
Other Name: Taxol


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01000896

Research Site
Matsuyama, Ehime, Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca Identifier: NCT01000896     History of Changes
Other Study ID Numbers: D8180C00020 
Study First Received: October 14, 2009
Last Updated: February 3, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase I
solid tumors
advanced solid malignancies
epithelial ovarian cancer
dose escalation
combination treatment
src inhibitor

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Lung Diseases
Lung Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Urogenital Neoplasms
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on February 09, 2016