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|Protocol||Trial Name and Objective|
Phase I/II Study of Weekly Abraxane and RAD001 in Women with Locally Advanced or Metastatic Breast Cancer. A Study of the Cancer Institute of New Jersey Oncology Group
The purpose of this study is to determine what dose of RAD001and Abraxane is safe to use when the two drugs are used at the same time. Other goals in this study are to learn about the effect of RAD001 and Abraxane on tumor growth; to find out what amount of RAD001 is present in the blood when it is combined with Abraxane; and to learn more about certain genes that produce proteins that may help predict or show an effect (a response to treatment) of this drug combination. Phase I: To determine the maximum tolerated dose (MTD) of RAD001 in combination of weekly Abraxane and determine the Phase II dose of RAD001.Phase II: To determine the activity on tumors, of the combination of RAD001 and Abraxane at the Phase II dose in patients with advanced breast cancer.
Phase I/II Randomized Trial of LBH589 (Pabinostat) at Two Dose Levels Combined with Bicalutamide (Casodex) in Men with Castration-Resistant Prostate Cancer
The purpose of this study is to determine the safety (Phase 1) and efficacy, or effectiveness (Phase 2) of an investigational drug, LBH589, in combination with Casodex® for the treatment of prostate cancer. The purpose of the Phase 1 study is to determine the maximum tolerated dose of investigational drug LBH589 in combination with Casodex®. The purpose of the Phase 2 study is to determine the effectiveness of investigational drug LBH589 in combination with Casodex® at the maximum tolerated dose, compared to a lower dose of LBH589 in combination with Casodex®.
Stereotactic Hypofractionated Accelerated Radiation and Prostatectomy in Patients with Elevated Risk (The SHARPER Trial - A Phase One Study)
1. Purpose/Specific Objectives
Autophagy inhibition to augment mTOR inhibition: A phase I/II trial of RAD001 and hydroxychloroquine in patients with previously treated renal cell carcinoma
Primary Objective Phase I
Phase I/II Study of Safety and Efficacy of Muscadine Plus (MPX) in Men with Prostate Cancer: A Randomized, Double-Blind Placebo Controlled Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer: Phase II
Phase II Primary Objective: To define the effects of placebo and two different daily doses of Muscadine Plus (MPX) on prostate specific antigen doubling time (PSADT) in men who have rising PSA after initial definitive therapy for localized prostate cancer.
NCI/CTEP 7998: A Phase I Study of ABT-888 in Combination with Cyclophosphamide in Solid Tumors or Non-Hodgkins Lymphoma
The main purpose of this study is to determine what is the best dose of ABT-888, a drug that prevents proteins from repairing DNA, in combination with cyclophosphamide, a chemotherapy drug that is commonly used to treat many types of cancer. Another goal of this study is to characterize the toxicities of combining ABT-888 and cyclophosphamide. In addition, the pharmacokinetics, or levels of each drug, will be assessed in the blood to evaluate how cyclophosphamide might alter the amount of ABT-888 that is eliminated from the blood.
NCI/CTEP #8850: A Phase I Trial of Riluzole and Sorafenib in Patients with Advanced Solid Tumors and Melanoma (CDUS)
The overall goal of this project is to determine if pharmacological blockade of the metabotropic glutamate receptor 1 (GRM1) signaling pathway with the agent Riluzole, combined with inhibition of RAF signaling with the agent Sorafenib, will result in clinically evident responses in patients with stage IV melanoma.
Phase I Study of Pazopanib in Combination with Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients with Advanced Solid Tumors
1.1 Primary Objective(s)
NCI/CTEP #8983: A Phase I Trial of MK-2206 and Hydroxychloroquine in Solid Tumors, Melanoma, Renal and Prostate Cancer to Examine the Role of Autophagy in Tumorigenesis
Primary - to define the maximum tolerated dose (MTD) of MK-2206 and hydroxychloroquine (HCQ) when used in combination.
TED12471: A Phase 1 dose-escalation study of the safety and pharmacokinetics of a tablet formulation of SAR245409 administered daily to patients with solid tumors or lymphoma
TED12414: International, multicenter, open-label, treatment-extension study for subjects who completed a Phase 1 or Phase 2 parental study to continue receiving treatment with SAR245408 or SAR245409 as a monotherapy or as a combination regimen.
To determine the long-term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in subjects who are benefiting from treatment.
CC-122-ST-001: A Phase IA/IB, Multi-center,Open-Label, Dose Finding Study To Assess The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotrophic Pathway modifier CC-122 administered orally to subjects with advanced solid tumors, NHL and Multiple Myeloma.
M13-695: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Oral Bioavailability of Veliparib Extended Release Formulations in Subjects with Solid Tumors
Assess and compare the bioavailability of three test extended release (ER) formulations of veliparib with that of the current imemdiate release formulation of veliparib. Evaluate the potential effect of food on the oral bioavailability of three test extended release (ER) formulations of veliparib. Establish the maximum tolerated dose (MTD) and to establish the recommended Phase 2 dose (RPTD) and schedule for one or more of the ER formulations. Secondary objectives of the study are to assess the safety and tolerability of the ER formulations.
TAC113886: A Phase I Dose Escalation Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study to Determine the Recommended Phase II Dose of GSK1120212 Dosed in Combination with GSK2141795
Primary: Part 1A: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination orally, once daily continuously. Part 1B: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination with an alternate schedule (i.e., at least one agent is dosed intermittently). Part 2A, 2B: To evaluate the clinical activity of GSK1120212 and GSK2141795 administered in combination in subjects with solid tumors that are predicted to be sensitive to the inhibition of MEK and/or AKT, including TNBC and BRAF-wild type melanoma.
NCI/CTEP# 8317: Phase II trial of cediranib alone or cediranib and lenalidomide in iodine 131-refractory differentiated thyroid cancer
Phase I Primary Objective: to determine the MTD of cediranib plus lenalidomide. Secondary objectives: (1) determine the response rate of cediranib in combination with lenalinomide in patients with iodine refractory, unresectable DTC who have evidence of disease progression within 12 months of study enrollment. (2) determine the toxicity, duration of response, progression free survival, and overall survival in patients with DTC treated with cediranib plus lenalidomide.