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This study has been withdrawn prior to enrollment.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:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01000896
First received: October 14, 2009
Last updated: February 3, 2010
Last verified: February 2010
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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
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 Lung Neoplasms Ovarian Neoplasms Neoplasms, Glandular and Epithelial Carcinoma, Bronchogenic Bronchial 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 Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013