SWOG S1304: A Phase II Randomized Study Comparing Two Doses of Carfilzomib with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease.
This study is for patients with multiple myeloma that is either refractory (has not responded to prior treatment) or is relapsed (has come back after prior treatment).
All subjects enrolled on this study will receive treatment with the drugs carfilzomib and dexamethasone given through a needle into a vein (IV). The purpose of the study is to compare a higher dose of carfilzomib to the lower dose which is approved for the treatment of myeloma to find out which dose is better. Subjects will be randomly assigned (like the flip of a coin) to either the high dose or the low dose. Subjects who receive the low dose whose disease comes back or gets worse may be switched to the high dose.
GS-US-325-1348: A Phase 1b Dose-Escalation Study Evaluating the Safety, Pharmacodynamics, Pharmacokinetics and Efficacy of GS-9901 in Subjects with Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphomas, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma
This study is for subjects with relapsed Follicular Lymphoma, Marginal Zone Lymphomas, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma. The study will see the safety of investigational drug called GS-9901. All subjects enrolled in this study will know the dose of the drug they will be taking. All subjects will take GS-9901, which will be taken continuously until unacceptable toxicity , disease progression, pregnancy, substantial noncompliance with study procedures or study drug, initiation of another anti-cancer or experimental therapy, study discontinuation, or withdrawal from study. In this study, 6 planned doses of GS-9901 will be tested. Each dose will be given to a maximum of 9 subjects. Once the highest dose is found, one or two selected doses will be tested in 40 additional subjects, for a total of about 120 subjects.
A Phase I/II, Multi-Center Study of Mocetinostat (MGCD0103) in Combination with Azacitidine in Subjects with Intermediate or High Risk Myelodysplastic Syndrome (MDS)
This is for patients who have been diagnosed with intermediate or high risk myelodyplastic syndrome (MDS).
The purpose of the study is to collect more information about the safety, especially about possible effects on the heart, of mocetinostat when given with azacitidine in patients with MDS. The study will explore safety and efficacy guidelines to ensure complete adherence to federal compliance and regulations.
Mocetinostat is an inhibitor of Class I HDACs currently in development for the treatment of patients with intermediate-2 and high-risk myelodysplastic syndromes (MDS). Mocetinostat has been studied in 13 clinical trials including 437 patients and the combination of mocetinostat and azacitidine showed a 93 percent disease control rate in 28 patients with MDS.
All subjects will receive standard of care treatment with azacitidine either intravenously (through a needle in a vein) or subcutaneously (a shot under the skin) for 7 days every 28 days. Subjects will also take mocetinostat or placebo (a pill that does not have any active medicine in it) 3 times a week. Subjects will not know whether they are receiving the active study drug or the placebo if they are in Cohort 3. All subjects in Cohort 2 will receive acive mocetinostat.
A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects with B-cell Malignancies
The purpose of the study is to find out if study drugs, ACP-196 and pembrolizumab, when given in combination will slow or stop the cancer from getting worse and whether the study drug has side effects. These 2 drugs have not been tested together previously.
This study is divided into 2 parts. Part 1 will enroll from 6 to 24 patients and Part 2 will enroll between 12 and 108 patients. Subjects will take ACP-196, an oral capsule, by mouth every day. Pembrolizumab will be administered in clinic once every 3 weeks over 30 minutes as an intravenous (IV) infusion and will begin the same day you take your first dose of ACP-196.