38 Solid Tumor/Phase I 2 1 0 30 34 109 http://clinicaltrials.dfhcc.harvard.edu/trials/109 AZD6244 in Cancers With BRAF Mutations The purpose of this research study is to determine if AZD6244 is safe and effective in treating patients with cancers with a mutated BRAF gene. AZD6244 is an investigational drug that works by blocking a protein called MEK, which is known to play a role in the growth of cancer cells lines and tumors that have a mutated BRAF gene. There are multiple types of cancers that have mutations in the BRAF gene and depend on the activity of this gene for their growth and survival. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 2 1160 http://clinicaltrials.dfhcc.harvard.edu/trials/1160 A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1/Phase 2 1112 http://clinicaltrials.dfhcc.harvard.edu/trials/1112 A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer This is a phase I/II clinical research study with BGT226, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a Phase I dose escalation part followed by a safety expansion part and a Phase II expansion part. Once the MTD has been defined, the safety expansion and efficacy expansion parts of the trial will be opened for enrollment. Phase I safety expansion part will enroll advanced solid tumors. Phase II expansion part will enroll advanced breast cancer. An effort will be made to enrich the trial population with Cowden Syndrome patients with advanced solid malignancies. Recruiting 3 Breast Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/3-breast-cancer 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1/Phase 2 360 http://clinicaltrials.dfhcc.harvard.edu/trials/360 Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose. Phase II expansion arms will investigate efficacy in patients with either HER2 positive or ER positive locally advanced or metastatic breast cancer. Additional patients with advanced solid malignancies will also be investigated in a separate expansion arm. Safety, pharmacokinetics and pharmacodynamics will be assessed. Recruiting 3 Breast Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/3-breast-cancer 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1/Phase 2 251 http://clinicaltrials.dfhcc.harvard.edu/trials/251 RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms The purpose of this research study is to determine the safety of the combination of RAD001 and CP-751,871, as well as the highest dose of this combination that can be given to people safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally. This drug has been extensively studied in many cancers. In particular, it has shown to be effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered drug that may stop tumor growth. It is currently being studied in a wide variety of cancers, and information from those other research studies suggests that these two drugs in combination may help to stop cancer growth. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 274 http://clinicaltrials.dfhcc.harvard.edu/trials/274 A Dose-Escalation Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer A dose-escalation trial designed to assess the safety and tolerability of treatment with ENMD-2076 administered orally over a range of doses in patients with advanced cancer that is refractory to current treatment or for which no curative therapy exists. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 346 http://clinicaltrials.dfhcc.harvard.edu/trials/346 A Safety Study of an Oral EGFR Inhibitor, AV-412, Administered Three Times Weekly in Advanced Solid Tumor Patients The Epidermal Growth Factor Receptor (EGFR) is a validated target for the treatment of cancer, and agents targeting EGFR such as erlotinib (Tarceva®) are approved by the FDA for treatment of various solid tumors. AV-412 is a novel inhibitor of the EGFR-tyrosine kinase, with added activity against Her2 and other oncogenic kinases. Based on evidence of preclinical activity in various solid tumors, AV-412 is being developed as a possible novel treatment for cancer in humans. PURPOSE: The purpose of this study is to test the safety and tolerability of AV-412, and determine the maximum tolerated dose of AV-412 when administered orally three times weekly. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 366 http://clinicaltrials.dfhcc.harvard.edu/trials/366 A Study of GDC-0941 in Patients With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD and BID. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 373 http://clinicaltrials.dfhcc.harvard.edu/trials/373 Safety Study of PRLX 93936 in Patients With Advanced Solid Tumors The purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it has on patients and their cancer. This study will also determine the highest dose of PRLX 93936 that can be given without causing adverse side effects and the dose of PRLX 93936 that should be used in future studies. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 14 http://clinicaltrials.dfhcc.harvard.edu/trials/14 Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors An open-label dose escalation study of patients with solid tumors treated with STA-9090 Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 102 http://clinicaltrials.dfhcc.harvard.edu/trials/102 Study of the Safety and Pharmacokinetics of XL147 in Adults With Solid Tumors The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects with solid tumors. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 202 http://clinicaltrials.dfhcc.harvard.edu/trials/202 A Trial of ALB 109564(a) in Subjects With Advanced Solid Tumors The purpose of this study is to determine the maximum tolerated dose of ALB 109564(a), a novel tubulin inhibitor, and to assess safety, pharmacokinetics, and anti-tumor activity in subjects with advanced solid tumors. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 228 http://clinicaltrials.dfhcc.harvard.edu/trials/228 Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement. Recruiting 12 Liver Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/12-liver-cancer 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 88 http://clinicaltrials.dfhcc.harvard.edu/trials/88 Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. The study will initially explore a dosing schedule every 7-days, which may be modified to longer intervals under certain circumstances. Once the maximum tolerated dose or recommended Phase 2 dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints. It is anticipated 2-3 study sites will participate in this trial. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 1337 http://clinicaltrials.dfhcc.harvard.edu/trials/1337 Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. The study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part 2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 195 http://clinicaltrials.dfhcc.harvard.edu/trials/195 Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 1348 http://clinicaltrials.dfhcc.harvard.edu/trials/1348 A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152. Recruiting 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i Phase 1 1180 http://clinicaltrials.dfhcc.harvard.edu/trials/1180 A Study Of Oral PF-02341066, A c-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1185 http://clinicaltrials.dfhcc.harvard.edu/trials/1185 Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630AM5) The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2-hour intravenous (IV) infusion (Part 1 of the trial), and as an 8-hour or 24-hour IV infusion (Part 2 of the trial). Each 3-week period is considered one treatment cycle. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1188 http://clinicaltrials.dfhcc.harvard.edu/trials/1188 Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug Irinotecan based on the side effects experienced by patients that receive both drugs Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1212 http://clinicaltrials.dfhcc.harvard.edu/trials/1212 A Dose Escalation Study of MK1775 in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adults With Advanced Solid Tumors This study will investigate MK1775 alone and in combination with one of the following three drugs: gemcitabine, cisplatin and carboplatin in patients with advanced solid tumors. The purpose of the study is to test safety and tolerability of MK1775 alone and in combination. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1221 http://clinicaltrials.dfhcc.harvard.edu/trials/1221 Study of MLN4924 in Adult Patients With Nonhematologic Malignancies This study is an open-label, multicenter, Phase 1, dose escalation study of MLN4924 in adult patients with nonhematologic malignancies. This study will be the first to administer MLN4924 in humans. The patient population will consist of adults with any form of nonhematologic malignancy for which standard, curative, life prolonging, or palliative treatment does not exist or is no longer effective. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1226 http://clinicaltrials.dfhcc.harvard.edu/trials/1226 Phase I Study of Intravenous Lipotecan® (TLC388 HCl for Injection) in Patients With Advanced Solid Tumors The purpose of this study is to find a safe and tolerable dose of Lipotecan® when administered to patients with advanced solid tumors. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1242 http://clinicaltrials.dfhcc.harvard.edu/trials/1242 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. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1252 http://clinicaltrials.dfhcc.harvard.edu/trials/1252 A Study Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-04554878 in patients with advanced non-hematologic malignancies, including patients with malignancies appropriate for serial biopsy. Screening consists of medical history, physical examination ECOG performance status, blood draws, a pregnancy test for female patients of childbearing potential, a FDG-PET and tumor imaging. Treatment consists of PF-04554878 pills continued until progression of disease, unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for biomarkers related to FAK and Pyk2 activities. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1254 http://clinicaltrials.dfhcc.harvard.edu/trials/1254 A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma 1258 http://clinicaltrials.dfhcc.harvard.edu/trials/1258 Study Evaluating Neratinib in Combination With Temsirolimus in Subjects With Solid Tumors The primary purpose of this study is to identify the maximum tolerated dose(s) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1200 http://clinicaltrials.dfhcc.harvard.edu/trials/1200 A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors. This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733, administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess two different dosing schedules; in one schedule R4733 will be administered on days 1, 2, 3, 8, 9, and 10 of each 21 day cycle, and in the other on days 1-7 of each 21 day cycle. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals. Recruiting 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1320 http://clinicaltrials.dfhcc.harvard.edu/trials/1320 Evaluation of the Efficacy and Safety of [18F]-ML-10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Solid Tumors to Radiation Therapy. The purpose of this study is to evaluate the potential of [18F]-ML-10 to serve as a non-invasive imaging tool for the early detection of response of brain metastases of solid tumors to radiation therapy. Such early detection may help early identification of responders and non-responders. The experimental design of the present study aims to evaluate the potential of non-invasive PET imaging with [18F]-ML-10 to address the currently unmet clinical need for early (within several days) distinction between a tumor that responds to the radiation therapy, and a tumor that does not respond to treatment. Currently, this distinction is available only after several weeks or months after completion of therapy, when tumor shrinkage can be detected by anatomical imaging (CT or MRI). Early detection of tumor responsiveness to treatment is now widely-recognized as a highly-desirable goal in oncology, and is respectively the target of intense research worldwide. In the future, the option to know early upon treatment administration, that the treated tumor is a non-responder, may improve clinical management of patients with brain metastases of solid tumors. Recruiting 2 Brain/Neuro Cancer http://clinicaltrials.dfhcc.harvard.edu/diagnoses/2-brain-neuro-cancer 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i 1251 http://clinicaltrials.dfhcc.harvard.edu/trials/1251 A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy. Recruiting 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma 38 Solid Tumor/Phase I http://clinicaltrials.dfhcc.harvard.edu/diagnoses/38-solid-tumor-phase-i