Solid Tumor/Phase I Clinical Trials

Showing 1-30 of 42 items
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  • A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors
  • This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC or other advanced solid tumors with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, three expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Study of Oral Rucaparib in Patients With gBRCA Mutation Breast or Ovarian Cancer, or Other Solid Tumor
  • The purpose of the first part of the study is to evaluate the safety of different doses of oral rucaparib given daily to patients with solid tumors. The purpose of the second part of the study is to determine the safety and clinical activity of oral rucaparib given daily to patients with locally advanced or metastatic breast cancer associated with a germline breast cancer (gBRCA) mutation and to patients with platinum-sensitive relapsed ovarian cancer associated with a gBRCA mutation who have received at least two, but no more than three, prior regimens (all platinum based).
  • Diagnoses: Solid Tumor/Phase I, Breast: Metastatic
  • Status: Recruiting
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  • A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors
  • This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate the MTD(s) and/or RP2D(s) for the combination of LGX818 and MEK162, followed by a Phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous schedule. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as 28 days. The dose escalation part of the trial will be conducted in adult patients with BRAF V600-dependent advanced solid tumors and is expected to enroll at least 18 patients. The dose escalation will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D declaration, patients will be enrolled in three Phase II arms. All patients will be followed for 30 days for safety assessments after study drugs discontinuation. All patients enrolled in the Phase II part of the study will be followed for survival.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Safety Study of XL765 in Combination With Erlotinib in Adults With Solid Tumors
  • The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Irinotecan and ABT-888 in Treating Patients With Metastatic or Unresectable Cancer
  • This phase I trial is studying the side effects and best dose of irinotecan given together with ABT-888 in treating patients with metastatic or unresectable cancer. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. ABT-888 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving irinotecan together with ABT-888 may kill more cancer cells
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Safety Study of PLX108-01 in Patients With Solid Tumors
  • PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. These tumors include, but are not limited to, acute myelogenous leukemia (Flt3), gastrointestinal stromal tumor and neurofibromatosis-1 (Kit), and glioma, breast cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, and osteosarcoma (Fms/CSF-1). The secondary objective is to measure the pharmacodynamic activity of PLX3397 via plasma and urine biomarkers of Fms activity.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma
  • LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6. CDK4/6 is involved in the process that allows both normal and cancer cells to divide and multiply. Cancer cells are often driven to divide and multiply by abnormalities that increase the activity of CDK4. Hence there is hope that blocking the activity of CDK4 may slow the growth of some cancers. LEE011 has shown anti-cancer activity in several different tumor models in animals. Because CDK4 is important in both normal and cancerous cells, LEE011 is expected to decrease the ability of the bone marrow to make white blood cells, platelets, and red blood cells. Although these effects are expected to be reversible, they can increase the risk of infection, bleeding and fatigue. The primary purpose of this study is to find the highest dose of LEE011 that can be safely given to adult patients with advanced solid tumors or lymphomas for which no further effective standard treatment is available. It will provide information about the side effects that may occur following treatment. The study will also possibly provide early evidence for LEE011's anti-tumor activity.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Safety Study of MGA271 in Refractory Cancer
  • The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors
  • In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis), a protein that causes tumor cell death. Because of these activities, slowing cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Veliparib and Dinaciclib With or Without Carboplatin in Treating Patients With Advanced Solid Tumors
  • This phase I trial studies the side effects and the best dose of veliparib and dinaciclib given together with or without carboplatin and to see how well they work in treating patients with advanced solid tumors. Veliparib and dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving veliparib and dinaciclib with or without carboplatin may kill more tumor cells
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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Showing 1-30 of 42 items
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