Pharmacology Core Active Trials as of 17 Sept. 2008

Analytical Core

• IRB#11108B: Phase I Study of R(+)XK469 in Patients with Advanced Solid Tumors and Lymphoma
• IRB#12044B: A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC664847) in Patients with Advanced Solid Tumors
• IRB#13274B: A Phase 1b Study Administering Rapamycin (Sirolimus) with Ketoconazole in Patients with Advanced Malignancies
• IRB#13934B: A Phase I Genotype-Directed Dose-Escalation Study of Irinotecan in Patients with Advanced Solid Tumors
• IRB#14341B: Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients with Advanced Hematologic Malignancies
• IRB#14435B: A Phase Ib Study Administering Rapamycin (Sirolimus) with Grapefruit Juice in Patients with Advanced Malignancies
• IRB#14908B: A Drug Interaction Study of Sorafenib (BAY 43-9006 tosylate) and Rapamycin in Patients with Advanced Malignancies
• IRB#15328B: A Pharmacokinetic Interaction Study of Rapamycin (Sirolimus) and SU11248 (Sunitinib) in Patients with Advanced Solid Tumors
• IRB#15878B: A Phase I study of Rapamycin (Sirolimus) with Bevacizumab in Patients with Advanced Malignancies

Biochemical Core

DNA Isolation from Whole Blood

• IRB#13362B - A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients with N2/N3 Locally Advanced Head and Neck Cancer
• IRB#13503A - Phase II Study of Skin Toxicity Dosing of IRESSA® (gefitinib) as Monotherapy in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
• IRB#13744 - Erlotinib and Bevacizumab integrated with standard chemotherapy for non-small cell lung cancer (NSCLC)
• IRB#13881 - Phase II Trial of Pemetrexed-Based Induction Chemotherapy Followed by Concomitant Chemoradiotherapy in Previously Irradiated Head and Neck Cancer Patients
• IRB#14018 - A Phase 2 Study of AZD2171 in patients with advanced renal cell carcinoma
• IRB#14203B - Phase II Study Of AZD2171 (NSC#732208) In Patients with Malignant Mesothelioma
• IRB#14401A - A Randomized Phase II Trial of Concurrent Chemoradiation with Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) versus Cextuximab (ERBITUX®), weekly Cisplatin, and Accelerated Radiation with Concomitant Boost (CetuxPX) after Cetuximab, Paclitaxel, Carboplatin Induction Chemotherapy in Patients with Locally Advanced Head and Neck Cancer
• IRB#14696A - Phase II trial of Sunitinib (SU11248) in Iodine-131 refractory, Unresectable differentiated thyroid cancers and medullary thyroid cancers
• IRB#15453B - A randomized, open-label Phase II study of BIBW 2992 versus cetuximab (Erbitux®) in patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) after failure of platinum-containing therapy with a cross-over period for progressing patients

Lymphocyte and Other Isolations from Whole Blood

• IRB#14110 – Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma
• Plasma and lymphocyte isolation from whole blood
• IRB#14115 – A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of XL184 Administered Orally to Subjects with Advanced Malignancies
• Plasma isolation and lymphocyte lysis and isolation from whole blood
• IRB#14470 - A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability and Maximum Tolerated Dose, of GRN163L in Patients with Refractory or Relapsed Solid Tumor Malignancies
• Isolation and gradual freezing of lymphocytes from whole blood
• IRB#14979 – A Phase II Study of XL647 in Subjects with Non-Small-Cell Lung
• Plasma isolation and lymphocyte lysis and isolation from whole blood
• IRB#15049B – Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer Who Are Refractory to or Not Suitable Candidates for 131 I Treatment
• Isolation of Circulating Endothelial Cells (CECs) from whole blood
• IRB#15209B – A Phase II Study of GSK1363089 Administered Orally to Subjects with Metastatic Gastric Cancer
• Isolation of plasma from whole blood
• IRB#15426 – Phase II Study of Dasatinib in Advanced Hepatocellular Carcinoma
• Isolation of cell pellet from whole blood
• IRB#15527B – A Phase 2 Study of the MET RTK Inhibitor XL880 in Subjects With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck
• Isolation of plasma from whole blood
• IRB#15539B – A Phase I/II, Open-Label, Multi-Center, Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD4877 Administered on Days 1, 2 and 3 in Adult Patients with Recurrent or Refractory Acute Myelogenous Leukemia (AML) Excluding Promyelocytic Leukemia
• Preparation of monoaster and tumor biological (bone marrow) slides from whole blood
• IRB#15763B – A Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PCI-24781 Administered Orally in Patients with Advanced Cancer
• Isolation of plasma and lymphocytes from whole blood
• IRB#15925B – DNA Methylation in Serum as a Predictive Marker of Progression and Survival Following Systemic Therapy in Patients with Metastatic Breast Cancer
• Isolation of plasma and pelleting of cells from whole blood
• IRB#16147 – A Phase I Study of SB1518 for the treatment of Advanced Myeloid Malignancies
• Isolation and treatment of plasma and lymphocytes with various additives
• IRB#16149 – A Phase 1/2 Study of XL184 with or without Erlotinib in Subjects with Non-Small Cell Lung Cancer
• Isolation of plasma from whole blood

All isolated samples are snap frozen in LN2 and then frozen
at -80°C until shipped out for analysis, unless otherwise noted.