|
|
|
|
|
|
Sponsored by: |
AstraZeneca |
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00600496 |
This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies.
Condition | Intervention | Phase |
Breast Cancer Breast Neoplasms Colon Cancer Colonic Cancer Colon Neoplasms Lung Cancer Melanoma Kidney Cancer |
Drug: AZD6244 Drug: Dacarbazine Drug: Erlotinib Drug: Docetaxel Drug: Temsirolimus |
Phase I |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer Kidney Cancer Lung Cancer Melanoma |
Drug Information available for: | Docetaxel Dacarbazine Erlotinib Erlotinib hydrochloride CCI 779 ARRY 142886 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | A Phase I, Open-Label, Multi-Center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors |
Estimated Enrollment: | 80 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
AZD6244 + docetaxel
|
Drug: AZD6244
twice daily oral dose
Drug: Docetaxel
intravenous infusion
|
2: Experimental
AZD6244 + Dacarbazine
|
Drug: AZD6244
twice daily oral dose
Drug: Dacarbazine
intravenous infusion
|
3: Experimental
AZD6244 + Erlotinib
|
Drug: AZD6244
twice daily oral dose
Drug: Erlotinib
intravenous injection
|
4: Experimental
AZD6244 + Temsirolimus
|
Drug: AZD6244
twice daily oral dose
Drug: Temsirolimus
intravenous infusion
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
United States, Michigan | |||||
Research Site | Recruiting | ||||
Detroit, Michigan, United States | |||||
United States, Pennsylvania | |||||
Research Site | Recruiting | ||||
Philadelphia, Pennsylvania, United States | |||||
United States, Tennessee | |||||
Research Site | Recruiting | ||||
Nashville, Tennessee, United States |
AstraZeneca |
Principal Investigator: | Patricia LoRusso, DO | Karmanos Cancer Institute |
Principal Investigator: | Roger Cohen, MD | Fox Chase Cancer Center |
Principal Investigator: | Jeffrey Infante, MD | Sarah Cannon Research Institute |
Responsible Party: | AstraZeneca ( Clive Morris, MD - Medical Science Director ) |
Study ID Numbers: | D1532C00004 |
First Received: | January 15, 2008 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00600496 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|
|