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This study has been withdrawn prior to enrollment.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..)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01000896
First received: October 14, 2009
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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
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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01000896

Locations
Japan
Research Site
Matsuyama, Ehime, Japan
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
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov 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
cancer
solid tumors
advanced solid malignancies
NSCLC
epithelial ovarian cancer
dose escalation
combination treatment
src inhibitor
Japanese

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
Neoplasms
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
Paclitaxel
Saracatinib
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on September 30, 2014