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| Sponsor: | Masonic Cancer Center, University of Minnesota |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01012362 |
Purpose
This is a Phase I study; dose escalating the combination of pazopanib when taken daily and ixabepilone when administered on day 1 of a 3 week treatment course.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Lung Cancer Colon Cancer Pancreatic Cancer Head and Neck Cancer Kidney Cancer Sarcoma Hepatocellular Cancer |
Drug: Pazopanib Drug: Ixabepilone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase I Study of Pazopanib and Ixabepilone in Patients With Solid Tumors |
| Estimated Enrollment: | 75 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pazopanib and Ixabepilone
Patient receives assigned dose level: Dose Level 1 = 400 milligrams (mg) of pazopanib and ixabepilone 25 mg/m2. Dose Level 2 = 400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 4 = 800 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. |
Drug: Pazopanib
Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.
Other Names:
Drug: Ixabepilone
Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle
Other Name: IXEMPRA(TM)
|
Treatment with ixabepilone will be given at an assigned dose as a 3 hour intravenous infusion on day 1 of a 21 day cycle. Treatment with pazopanib will be given at an assigned dose by mouth once a day, beginning on day 1 and continuing daily. Disease assessment will be done every 2 cycles (6 weeks) with treatment continuing until disease progression, unacceptable toxicity or patient refusal.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function within 14 days of enrollment defined as:
Exclusion Criteria:
History of any one or more of the following cardiovascular conditions within the past 6 months:
Contacts and Locations| United States, Minnesota | |
| Masonic Cancer Center, University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | Arkaduisz Z Dudek, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | Arkadiusz Dudek, M.D., Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01012362 History of Changes |
| Other Study ID Numbers: | 2009LS001, 0906M68402, NCI-2009-01444 |
| Study First Received: | November 12, 2009 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Solid tumor malignancy breast cancer lung cancer colon cancer pancreatic cancer |
head and neck cancer kidney cancer sarcoma hepatocellular cancer |
|
Breast Neoplasms Colonic Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Head and Neck Neoplasms Lung Neoplasms Pancreatic Neoplasms Sarcoma Carcinoma, Hepatocellular Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Colorectal Neoplasms Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Respiratory Tract Neoplasms |