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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This study has been withdrawn prior to enrollment.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
Cancer Non Small Cell Lung Cancer Epithelial Ovarian Cancer Drug: AZD0530 Drug: Carboplatin Drug: paclitaxel Phase 1

Study Type: Interventional
Study Design: 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

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. ]

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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on September 21, 2017