Alisertib is orally available small molecule inhibitor of Aurora A kinase that plays important role in cell mitosis. This Phase I study evaluates the effect of food on the pharmacokinetics of Alisertib in patients with advanced solid tumors or lymphomas.
AV-203 is a monoclonal antibody that selectively targets the receptor ERBB3 and inhibits its activity. This receptor is expressed in many human cancers and is associated with cancer growth and survival and in development of resistance to anti-cancer agents. In this Phase I study AV-203 is administered intravenously once every 2 weeks in patients with metastatic or advanced solid tumors.
BAX69 is an anti-macrophage migration inhibitory factor (anti-MIF) antibody. MIF is a pro-inflammatory cytokine that is up-regulated in many human cancers and contributes to growth, angiogenesis and migration of cancer cells. BAX69 is administered intravenously every 2 weeks in a 28 day cycle in patients with malignant solid tumors.
BGJ398 is an orally bioavailable inhibitor of human fibroblast growth factor receptor (FGFRs) with potential antiangiogenic and antineoplastic activities. BYL719 is an oral selective PI3K a isoform inhibitor. In this Phase I study BGJ398 in combination with BYL719 is administered in patients with select solid tumors that have PIK3CA gene mutation with or without FGFR genetic alteration.
BT062 is an immunoconjugate consisting of anti CD138 antibody and cytotoxic agent maytansinoid DM4. CD138 is over-expressed on multiple myeloma cells compared to normal plasma cells. BT062 will be administered on days 1, 8 and 15 with Lenalidomide once daily on days 1-21 in patients with relapsed or refractory multiple myeloma.
Cabazitaxel is a new taxoid, which promotes tubulin assembly and has shown strong antitumor activity against a broad spectrum of tumor models including those sensitive as well as resistant or refractory to other taxanes such as docetaxel. This is a Phase I safety and pharmacokinetic study of XRP6258 (Cabazitaxel) in advanced solid tumor patients with varying degrees of hepatic impairment.
Carfilzomib is a selective proteasome inhibitor. This Phase I study is evaluating the safety of Carfilzomib in patients with advanced solid tumors or hematological malignancies and varying degrees of hepatic impairment. It is administered on days 1, 2, 8, 9, 15, and 16 during a 28 day cycle.
CBL0137 is a small molecule in the carbazole family affecting p53 and NF-kappa B signal transduction pathways. It is administered intravenously on days 1, 8 and 15 every 28 days in patients with metastatic or advanced solid tumors and refractory lymphomas.
CFG920 is a non-steroidal, reversible dual inhibitor of CYP17 and CYP11B2 with potential antiandrogen and antineoplastic activities. In this Phase I/II study CFG920 will be administered orally in patients with metastatic castration-resistant prostate cancer after progressing (or have refused) on Abiraterone and Docetaxel.
Crizotinib is orally bioavailable ALK and c-MET/HGFR receptor tyrosine kinases inhibitor. This Phase I study evaluates the effect of hepatic impairment on the pharmacokinetics and safety of Crizotinib in advanced cancer patients with solid tumors.
Dasatinib is an oral tyrosine kinase inhibitor of SRC family, BCR-ABL, c-kit, EPHA2 and PDGFß receptors. It is administered in advanced cancer patients with varying levels of liver dysfunction.
GSK2118436 is an orally bioavailbale inhibitor of B-raf protein which may inhibit the proliferation of tumor cells with mutated BRAF gene. It is administered in patients with V600 BRAF mutation positive tumors. Previous exposure to BRAF inhibitors is allowed.
Halaven is a synthetic analogue of the marine spong natural product halichondrinB. As an inhibitor of microtubules it blocks the cell division and leads to apoptosis of the cancer cells. In this study Halaven is administered on days 1 and 8 of a 21 day cycle in patients with solid tumors who also have impaired renal function.
IMGN 529 consists of CD37 targeting humanized monoclonal antibody and cytotoxic maytansinoid DM1. In this Phase I study IMGN529 is administered intravenously every 3 weeks to patients with relapsed or refractory Non-Hodgkin’s lymphoma.
IMGN853 is an immunoconjugate consisting of the humanized monoclonal antibody against folate receptor 1 (FOLR1) conjugated to the cytotoxic maytansinoid DM4. It is administered once every 21 days intravenously in patients with advanced solid tumors with FOLR1 expression. Tumor types which have a high incidence of FOLR1 positivity (serous or endometroid epithelial ovarian cancer, serous endometrial cancer, NSCLC of adenocarcinoma and bronchoalveolar cancer and clear cell renal carcinoma) can enroll without the specific testing.
LDE225 is an oral selective Smo antagonist that downregulates the Hedgehog signal transduction pathway. In this Phase I study the patients with advanced solid tumors receive LDE225 with Warfarin or Bupropion to evaluate the drug-drug interaction.
M402 is a heparin sulfate mimetic designed to have antitumor effect without the anticoagulant activity. In this Phase I/II study M402 is administered as daily subcutaneous injection with Gemcitabine in patients with metastatic pancreatic cancer who have not received prior chemotherapy.
Onartuzumab is a monoclonal antibody directed against the hepatocyte growth factor receptor (c-Met). In this Phase I study Onartuzumab is administered intravenously as a single agent and in combination with Sorafenib in patients with advanced hepatocellular carcinoma. Study has 2 arms: one will enroll patients who have received one previous systemic therapy and the other will enroll systemic treatment naïve patients.
RO5429083 is a humanized monoclonal antibody that binds to CD44, a transmembrane glycoprotein that is expressed in many cells, but what seems to have a more critical role in malignant growth. It is given as an IV infusion once every 2 weeks in patients with metastatic and/or advanced solid tumors that express CD44.
Description: This is a Phase I/II study of RAD001 (everolimus) for patients with glioblastoma or gliosarcoma (brain tumor). Patients are randomized to receive RAD 001 with the standard treatment of radiation plus temozolomide (oral chemotherapy) or to receive the standard treatment of radiation plus temozolomide alone.
TKI258 is a potent receptor tyrosine kinase inhibitor (TKI) that selectively targets VEGFR, FGFR, PDGFR, CST1R, c-KIT, RET, TrkA and FLT3. It is expected to inhibit cellular proliferation and inducing cancer cell apoptosis. TKI258 is administered orally in patients with impaired liver function.