This is a Phase II study of ACE-041 for patients with recurrent or metastatic squamous cell carcinoma of the head and neck. ACE-041 is a recombinant protein that is administered once every three weeks by SC injection and targets ALK1.
AVL-292 is a selective, orally administered, inhibitor of Bruton’s tyrosine kinase (Btk). The expression of Btk is found on B-lymphocytes and has been implicated in the growth and survival of certain B-cell lymphomas as well as in CLL. This is a Phase Ib, escalating dose study of AVL-292 as a monotherapy in subjects with relapsed and/or refractory B-cell non-hodgkin lymphoma, chronic lymphocytic leukemia, and Waldenstrom’s macroglobulinemia
AVL-292 is a selective, orally administered, inhibitor of Bruton’s tyrosine kinase (Btk). The expression of Btk is found on B-lymphocytes and has been implicated in the growth and survival of certain B-cell lymphomas as well as in CLL. This is a Phase Ib, escalating dose study of AVL-292 as a monotherapy in subjects with relapsed and/or refractory B-cell non-hodgkin lymphoma, chronic lymphocytic leukemia, and Waldenstrom’s macroglobulinemia
This Phase II study of cetuximab in combination with docetaxel, cisplatin, bevacizumab and radiation in patients with locally advanced head and neck cancer. Cetuximab binds to epidermal growth factor receptor and blocks the activity of epidermal growth factor.
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.
G-202 is a pro-drug, consisting of cytotoxic analog of thapsigargin and a peptide to activate it at the tumor site. It is administered by intravenous infusion daily for 3 consecutive days on a 28 day cycle in patients with advanced hepatocellular carcinoma after progression on Sorafenib therapy.
GA101 is a humanized third generation monoclonal antibody that binds to CD20, expressed in cancerous B cells. In preclinical studies it shows greater antibody-dependent cellular cytotoxicity than other CD20 antibodies and can so be potentially more effective. In this Phase II study GA101 is administered in combination with CHOP chemotherapy in patients with previously untreated advanced diffuse large B-cell lymphomas.
IMC-A12 is a recombinant human antibody that binds to VEGFR-2 blocking the action of VEGF ligand. This approach inhibits the growth of blood vessels that provide the tumor with nutrients and energy. This Phase II study combines IMC-A12 with Paclitaxel and Carboplatin in patients with advanced non-squamous, non-small cell lung cancer.
INNO-206 is an albumin-binding prodrug of Doxorubicin developed to improve the therapeutic effects of Doxorubicin and to decrease the toxicities. In this randomized Phase II study patients with metastatic, locally advanced, or unresectable soft tissue sarcoma will receive INNO-206 or Docorubicin intravenously once every 3 weeks.
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.
Metformin is widely used anti-diabetic medicine. It can also act as an anti-cancer agent by activation of AMP-activated protein kinase (AMPK) pathway and subsequent inhibition of mTOR that blocks the cancer cell growth and proliferation. It may also lessen the symptoms of metabolic syndrome caused by androgen deprivation therapy. In this Phase II study patients with advanced prostate cancer will be randomly selected to receive castration only or castration plus metformin as first line treatment.
MLN4924, Nedd8-activating enzyme inhibitor, is administered intravenously on days 1, 3 and 5 of a 21 day cycle in patients with AML and high-grade myelodysplastic syndrome.
MLN8237 is an oral selective small molecule inhibitor for Aurora A kinase. Aurora A kinase has a regulatory roll in cell mitosis and is over-expressed in many tumors. In the Phase I part of the study MLN8237 is taken twice a day for 7 days every 21 days with Rituximab and in the Phase II part of the study with Rituximab and Vincristine by patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are CD 20 positive.
For veterans only; Patients will take Nexrutine® (an oral dietary supplement) prior to and during radiation treatment for prostate cancer or prior to surgery for prostate cancer. The purpose of the study is to see whether taking Nexrutine® will cause the PSA (Prostate Specific Antigen) to decline.
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.
MLN8237 is an oral selective small molecule inhibitor for Aurora A kinase. Aurora A kinase has a regulatory roll in cell mitosis and is over-expressed in many tumors. In this Phase II study MLN8237 is taken twice a day on days 1-7 every three weeks by patients with relapsed or refractory peripheral T-cell Non-Hodgkin lymphoma.
SAHA is a HDAC inhibitor. SAHA may also block angiogenic signaling by inhibiting the VEGF receptors expression and also reduce circulating levels of inflammatory cytokines. In this study SAHA is administered with Hydroxychloroquine in patients with advanced solid tumors
SAHA is a HDAC inhibitor. SAHA may also block angiogenic signaling by inhibiting the VEGF receptors expression and also reduce circulating levels of inflammatory cytokines. In this study SAHA is administered with Hydroxychloroquine in patients with advanced solid tumors
TH-302 is a drug that is inert unless activated by enzymes present under low oxygen condition. As many cancer types have low oxygen supply due to the rapid consumption by tumor cells, TH-302 is then broken down in these tumors to its active form which then can kill cancer cells. TH-302 will be administrated on days 1 and 15 with Bevacizumab in patients with recurrent high grade astrocytoma following progression with combined treatment with radiation and temozolomide and also after anti-angiogenic treatment.
Tivozanib is an oral VEGF receptor tyrosine kinase inhibitor. Patients with renal cell carcinoma who have received no prior systemic therapy for mRCC will be randomized to receive Tivozanib or Sunitinib for 12 weeks after what they will cross over for the other study drug they did not receive during the first 12 weeks.