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CLINICAL TRIALS - SUMMER 2008
Phase I Studies

AMG 820 is an investigational oncology therapeutic antibody. AMG 820 will be given by intravenous infusion weekly to subjects with solid tumors.

AVE0005 is VEGF trap, a fusion protein consisting of the extracellular domains of VEGF-R1 and VEGF-R2, which binds to circulating VEGF. It is given intravenously every two weeks with erlotinib and weekly gemcitabine. This study is designed for advanced solid tumors.

AVE1642 is a monoclonal antibody directed to the IGF-1R and is combined with docetaxel chemotherapy. This study is for patients with advanced malignancies.

BAY 73-4506 is a multi-targeted kinase inhibitor that blocks tumor growth through multiple targets (i.e. Raf-1, BRAF, VEGFR 2/3, c-kit, PDGFR, and FGFR-1). In this study, the drug is given orally on a continuous dosing schedule.

BIIB015 is a humanized, IgG1, DM4-conjugated, anti-cripto, monoclonal antibody. BIIB015 is given as an intravenous infusion. This study is for patients with relapsed or refractory cripto-positive solid tumors.

BIIB021 is an oral, fully synthetic non-geldanaycin, selective inhibitor of activated heat shock protein 90 (Hsp90). BIIB021 is administered orally once or twice daily. This study is open to subjects with advanced solid tumors.

BMS-582664 (Brivanib) is a small molecule inhibitor of VEGF-2 and FGF receptor kinases. BMS-582664 will be given orally on a continuous basis. This study is open to patients with advanced solid tumor malignancies and normal hepatic function or HCC and varying levels of hepatic impairment.

BMS-833923 (XL139) is an oral Smoothened (SMO) antagonist capable of inhibiting the Hedgehog (HH) signaling pathway. BMS-833923 will be given orally on daily schedules to subjects with solid tumors.

BSI-201, a PARP-1 inhibitor, is given intravenously twice weekly. BSI-201 is combined with either topotecan, temozolomide, gemcitabine or carboplatin/paclitaxel. This study is for patients with advanced solid tumors.

CALAA-01 is a targeted nanoparticle complex that contains anti-R2 siRNA. CALAA-01 is given intravenously. This study is for patients with advanced solid tumors.

PX-171-007; Carfilzomib is a second generation proteasome inhibitor, and is given intravenously twice weekly for 3 weeks of a 4 week cycle. This activity seeking study is intended for patients with advanced solid tumors.

CNTO 888 is a monoclonal antibody. CNTO 888 is given by intravenous infusion. This study is for patients with advanced solid tumors.

CP-870,893 is the prototype CD40 agonist antibody. In this study, CP-870,893 will be given in combination with chemotherapy (paclitaxel and carboplatin). CP-870,893 will be administered as an intravenous solution and the chemotherapy will also be administered by intravenous infusion. This study is for subjects with metastatic solid tumors.

CUDC-101 is an inhibitor of HDAC, EGFR and Her2. CUDC-101 will be given as an intravenous infusion for 5 consecutive days every 14 days. This study is for subjects with advanced and refractory solid tumors.

CYC116 is an oral aurora kinase inhibitor. CYC116 is given orally. This study is for patients with solid tumors.

EZN-2208 is pegylated SN-38, the active metabolite of irinotecan, and is given intravenously once a week for 3 weeks of a 4 week cycle. This study is intended for patients with advanced solid tumors or lymphoma.

EZN-2968 is an LNA AS-ODN (locked nucleic acid antisense oligodeoxynucleotide).that binds to HIF-1a mRNA and leads to its destruction. EZN-2968 will be given by intravenous infusion for 5 continuous days every 4 weeks to subjects with solid tumors or lymphoma.

FP-1039 is a fusion protein consisting of fibroblast growth factor receptor 1 linked to the Fc region of human immunoglobulin G1. In this study, FP-1039 is administered intravenously once a week. This study is open to subjects with solid tumors.

GPX-150 is an analog of doxorubicin. In this study, GPX-150 is given intravenously once every three weeks to patients with solid tumors.

huC242-DM4 is an immunoconjugate, directed against the CanAg tumor antigen, consisting of a humanized monoclonal antibody conjugated to the maytansinoid toxin DM4. In this study, huC242 DM4 is given intravenously once every three weeks to patients with solid tumors.

IMGN388 is a human IgG1 anti-integrin antibody conjugated to the maytansinoid, DM4. IMGN388 will be given by intravenous infusion once every 21 days. This phase I study is for patients with solid tumors.

 

LY2523355 is an inhibitor of the "microtubule" motor protein EG5, which is essential for both normal and cancer cell mitosis. LY2523355 will be given by intravenous infusion on Days 1, 5 and 9 every 21 days to subjects with advanced cancer including non-Hodgkin’s lymphoma.

MK-2206 is a potent inhibitor of serine/threonine kinases, and will be given orally every other day to patients with advanced solid tumors.

MP470 is a novel, oral, multi-targeted tyrosine kinase inhibitor (TKI). In this study, MP470 is given orally on a daily schedule to patients with solid tumors.

MP470 is a novel, oral, multi-targeted tyrosine kinase inhibitor (TKI). In this study MP470 is given orally in combination with standard-of-care chemotherapy regimens. This study is for patients with solid tumors.

Patupilone (EPO906) is a natural microtubule targeting cytotoxic agent isolated from myxobacteria. Patupilone will be given by intravenous infusion once every three weeks to patients with solid tumors and varying degrees of liver function.

PHA-739358 is an aurora kinase inhibitor. It is given intravenously in combination with docetaxel or gemcitabine or bevacizumab. This study is for patients with solid tumors, including Hodgkin’s and non-Hodgkin’s lymphoma.

PR-104 is a pre-prodrug (precursor of a prodrug) designed to become an active cytotoxin (alkylator) in hypoxic regions of tumors. PR-104 will be given by intravenous infusion once every 3 weeks to subjects with solid tumors.

R4733 (RO4929097) is a potent and selective inhibitor of y-secretase producing inhibitory activity of Notch signaling in tumor cells. R4733 is given orally. This study is for patients with refractory metastatic or locally advanced solid tumors.

R7112 is a small molecule antagonist of the MDM2 E3 ligase. It blocks protein-protein interaction between MDM2 and p53wt tumor suppressor protein. R7112 will be given orally on different schedules to subjects with advanced malignancies except leukemia.

SCH 900105 is a humanized anti-Hepatocyte Growth Factor (HGF) IgG1 monoclonal antibody. SCH 900105 will be given as an intravenous infusion once every 14 days. This study is for subjects with advanced solid tumors or lymphomas.

SPI-1620 is an investigational ETB agonist being evaluated for its ability to enhance blood flow and delivery of antineoplastic agents to solid tumors. SPI-1620 is given intravenously in combination with docetaxel. This study is for patients with carcinomas.

Topotecan liposome injection (TLI) is a new formulation of topotecan. TLI will be administered by intravenous infusion to patients with solid tumors.

XL765 is a potent small molecule inhibitor of PI-3K and mTOR. This study evaluates XL765 given orally twice daily in patients with solid tumors.

YM155 is a survivin inhibitor that is being evaluated with docetaxel and prednisone in men with advanced hormone refractory prostate cancer. YM-155 is given as a 168hr continuous infusion.

PF-00299804 is a potent and selective irreversible small molecule inhibitor of the HER family of tyrosine kinases (i.e., HER-1, HER-2, and HER-4). PF-00299804 will be given orally by mouth everyday in combination with oral Dextromethorphan, an approved cold drug. Dextromethorphan will be given once 3 days before starting PF-00299804 and again 31 days later. This study is for subjects with advanced malignant solid tumors.

PF-00299804 is a potent and selective irreversible small molecule inhibitor of the HER family of tyrosine kinases (i.e., HER-1, HER-2, and HER-4). PF-00299804 will be given orally by mouth everyday in combination with CP-751,871, a fully human monoclonal antibody against the insulin-like growth factor type I receptor (IGF-IR). CP-751,871 will be given as an intravenous infusion once every 21 days. This study is for subjects with advanced solid tumors.

Phase II Studies

AMG 479 is a fully human monoclonal antibody (IgG1) against the insulin-like growth factor receptor-1 (IGF-1R). AMG 479 is given as an intravenous infusion. This study is for subjects with relapsed or refractory Ewing’s family tumors and desmoplastic small round cell tumors.

huC242-DM4 -- The CanAg tumor antigen is frequently expressed in gastric cancer. In this study, huC242-DM4 is given intravenously once every three weeks to patients with metastatic gastric or gastroesophageal junction cancer

YM155 is a survivin inhibitor that is being evaluated as a single agent therapy in patients with refractory diffuse large B-cell lymphoma. It is given as a 168hr continuous infusion. Patients who have failed SCT are eligible.

Phase III Studies

AVE8062 is an antitumor-antivasculature agent. In this study AVE8062 or placebo will be given intravenously once every three weeks in combination with cisplatin. This study is for patients with advanced-stage soft tissue sarcoma.

Contact
Tracy Dufresne, RN, BSN, OCN, CCRP
Physician Referral Coordinator

Phone: 210-593-5265
Fax: 210-615-1075
E-mail: tracy.dufresne@start.stoh.com
4319 Medical Drive, Suite 205
San Antonio, TX 78229

  Phone: (210) 593-5250
Fax: (210) 615-1121
 
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