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1482 Results for

Study Title Principal Investigator
A Phase 1 and Pharmacokinetic Study of Dabrafenib (GSK2118436B) in Patients With BRAFV600X Mutations and Renal or Hepatic Dysfunction
PRIMARY OBJECTIVES: I. To determine the toxicity profile and the maximum tolerated doses (MTDs) of dabrafenib in patients with v-raf murine sarcoma viral oncogene homolog B1 (BRAF)^V600X mutations and renal or hepatic dysfunction. SECONDARY OBJECTIVES: I. To assess for tumor response and various times to clinical event. II. To provide dosing recommendations for dabrafenib in patients with varying degrees of hepatic and renal dysfunction for possible inclusion in the label. TERTIARY OBJECTIVES: I. To assess the pharmacokinetic and pharmacogenetic profile of dabrafenib and active metabolites. OUTLINE: This is a dose-escalation study. Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 (once daily [QD] on day 1 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Not recruiting | | Multisite
Ramesh Ramanathan
A Phase1-2 Pharmacokinetic Guided Dose-Escalation and Dose-Confirmation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 With Oral Decitabine in Subjects With Myelodysplastic Syndromes (MDS)
Dose levels for the study's second stage will be based on safety and pharmacokinetics.
Not recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Mohammad Azab
A Phase II Simon Two-Stage Study of the Addition of Pracinostat to a Hypomethylating Agent (HMA) in Patients With Myelodysplastic Syndrome (MDS) Who Have Failed to Respond or Maintain a Response to the HMA Alone
Not recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Guillermo Garcia-Manero
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