CLINICAL TRIALS PROFILE FOR CAPRELSA
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All Clinical Trials for CAPRELSA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00459121 ↗ | Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery | Terminated | National Cancer Institute (NCI) | Phase 2 | 2007-07-01 | RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving vandetanib together with carboplatin and paclitaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery. |
| NCT00459121 ↗ | Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery | Terminated | Barbara Ann Karmanos Cancer Institute | Phase 2 | 2007-07-01 | RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving vandetanib together with carboplatin and paclitaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery. |
| NCT00514046 ↗ | Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer | Completed | National Cancer Institute (NCI) | Phase 1/Phase 2 | 2007-07-20 | Background: - Medullary thyroid carcinoma (MTC) is common in people with a genetic disorder called multiple endocrine neoplasia (MEN). - Vandetanib is an experimental drug that blocks a defective protein receptor (rearranged during transfection (RET) receptor) found on the surface of cancer cells in people with MEN. It is thought that this protein is a primary cause of MTC in people with MEN. Objectives: - To study the activity of Vandetanib in children and adolescents with MEN-related MTC by measuring the change in tumor size, in blood levels of proteins produced the tumor (calcitonin and carcinoembryonic antigen (CEA) and in tumor-related diarrhea. - To determine the safety and tolerability of Vandetanib in children and adolescents. - To study how the body handles Vandetanib in children and adolescents. - To determine the effect of Vandetanib on the survival of children and adolescents with MTC. Eligibility: -Children and adolescents 5 to 18 years of age with MTC whose tumor cannot be surgically removed or has grown back after treatment or has metastasized (spread beyond the thyroid gland). Design: - Patients take Vandetanib once a day in 28-day cycles. The first patients enrolled in the study are started on a low dose of Vandetanib to determine tolerability. - Patients have periodic blood tests, electrocardiograms, and blood pressure measurements to look for side effects of Vandetanib. - Blood tests and imaging scans (magnetic resonance imaging (MRI), computed tomography (CT), bone and octreoscan) are done every 8 weeks for the first 32 weeks of treatment and then every 16 weeks for the duration of the treatment period. - Patients who have tumor-related diarrhea keep a daily record of the number and consistency of bowel movements. |
| NCT00923247 ↗ | A Targeted Phase I/II Trial of ZD6474 (Vandetanib; ZACTIMA) Plus the Proteasome Inhibitor, Bortezomib (Velcade ), in Adults With Solid Tumors With a Focus on Hereditary or Sporadic, Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC) | Terminated | National Cancer Institute (NCI) | Phase 1/Phase 2 | 2009-02-19 | Background: - The combination of anti-cancer drugs vandetanib (given orally) and bortezomib (given intravenously) has not been used in humans. However, both drugs have been studied separately. Bortezomib has been approved by the U.S. Food and Drug Administration (FDA) for treating multiple myeloma and mantle cell lymphoma, while vandetanib is still under investigation pending FDA approval. - Both bortezomib and vandetanib are under investigation for use in treating certain kinds of cancer. Researchers hope that the combination of these two drugs will be more effective than either of them alone. Objectives: - To determine if the combination of vandetanib and bortezomib will decrease the amount of the cancer and, if it does, to determine how long the response will last. - To determine any side effects that may occur with this combination of treatments. - To determine what doses of each drug are well tolerated and safe when given together. - To study genetic mutations in tumors to better understand how tumors grow and how these drugs interact with the tumor. Eligibility: - Patients 18 years of age and older with solid tumors that cannot be surgically removed and have either recurred or shown further growth. The tumor(s) must be able to be evaluated by X-ray, MRI (magnetic resonance imaging), and CT (computerized tomography) scanning. - Patients who have been diagnosed with medullary thyroid cancer will participate in Phase II of the study. Design: - Tumor samples may be taken at the start of the study for research purposes. - Phase I: Patient groups will be treated on an outpatient basis with vandetanib and bortezomib, given at increasing doses over four different levels to determine the maximum tolerated dose calculated by height and weight: - Doses will be given on Days 1, 4, 8, and 11 for each 28-day cycle. - Two additional levels (Level 1A and Level 1B) may be included in the study, depending on side effects at various levels. - Phase II: Patients with medullary thyroid cancer will be divided into two groups, with two patients in Group A for every one patient in Group B. No placebo will be involved in this study. - Group A: Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study. - Group B: Patients will be treated with bortezomib alone. - A second tumor sample may be taken. In patients with thyroid cancer, the second biopsy will be done at the 6-week evaluation (approximately 42 days after beginning). In patients with cancer other than thyroid cancer, the second biopsy will be obtained on Day 4 of either the first or second cycle, after the bortezomib infusion. - The effects of the drugs will be studied through blood samples and CT scans taken during and after various drug cycles. |
| NCT01539655 ↗ | Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib | Completed | Sanofi | Phase 1 | 2012-02-01 | Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib |
| NCT01544140 ↗ | Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib | Completed | Sanofi | Phase 1 | 2012-04-01 | The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib. |
| NCT01551615 ↗ | A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib | Completed | Sanofi | Phase 1 | 2012-03-01 | Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone and In Combination with Vandetanib |
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