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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00712504 |
Purpose
This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors Non Small Cell Lung Cancer |
Drug: sunitinib Drug: docetaxel |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors |
| Enrollment: | 49 |
| Study Start Date: | July 2004 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
SU011248 in combination with docetaxel
|
Drug: sunitinib
25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)
Drug: docetaxel
60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Advanced solid tumor malignancy ECOG 0 or 1
Exclusion Criteria:
Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy
Contacts and Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35233 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35233-2115 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53792 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6181035 |
| Study First Received: | July 7, 2008 |
| Last Updated: | November 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00712504 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (SUTENT), docetaxel (Taxotere), Angiogenesis Inhibitors |
|
Docetaxel Thoracic Neoplasms Respiratory Tract Diseases Sunitinib Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Angiogenesis Inhibitors Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Sunitinib Therapeutic Uses Lung Diseases Growth Inhibitors Angiogenesis Modulating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
