Abstract

Phase I clinical trials are the culmination of the costly and laborious preclinical screening process and are the foundation for studies of human antitumor activity. The University of Wisconsin has had continuous NCI funding for its phase I studies since 1979. This proposal details our extensive experience in conducting phase I trials and outlines our goals for continuation of such work as detailed in our specific aims: ? Aim 1: Determination of Dose Limiting Toxicity and Maximum Tolerated Dose in Early Phase Trials ? Aim 2: Definition of Pharmacokinetic and Pharmacodynamic Endpoints in Phase I Clinical Trials ? Aim 3: Molecular Target Assessment in the Determination of Drug Mechanisms, Biologic Endpoints, and Response ? Aim 4: New Designs and Paradigms for the Evaluation of Novel Agents ? ? ?

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01CA062491-14
Application #
7228191
Study Section
Special Emphasis Panel (ZCA1-SRRB-E (O1))
Program Officer
Ivy, S Percy
Project Start
1998-02-27
Project End
2008-02-29
Budget Start
2007-03-21
Budget End
2008-02-29
Support Year
14
Fiscal Year
2007
Total Cost
$558,617
Indirect Cost

  Institution

Name
University of Wisconsin Madison
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715

  Publications

Kyriakopoulos, Christos E; Braden, Amy M; Kolesar, Jill M et al. (2017) A phase I study of tivantinib in combination with temsirolimus in patients with advanced solid tumors. Invest New Drugs 35:290-297
Rampurwala, Murtuza; Wisinski, Kari B; Burkard, Mark E et al. (2017) Phase 1b study of orteronel in postmenopausal women with hormone-receptor positive (HR+) metastatic breast cancer. Invest New Drugs 35:87-94
Pili, Roberto; Liu, Glenn; Chintala, Sreenivasulu et al. (2017) Combination of the histone deacetylase inhibitor vorinostat with bevacizumab in patients with clear-cell renal cell carcinoma: a multicentre, single-arm phase I/II clinical trial. Br J Cancer 116:874-883
Wisinski, Kari B; Tevaarwerk, Amye J; Burkard, Mark E et al. (2016) Phase I Study of an AKT Inhibitor (MK-2206) Combined with Lapatinib in Adult Solid Tumors Followed by Dose Expansion in Advanced HER2+ Breast Cancer. Clin Cancer Res 22:2659-67
Deming, Dustin A; Cavalcante, Ludmila L; Lubner, Sam J et al. (2016) A phase I study of selumetinib (AZD6244/ARRY-142866), a MEK1/2 inhibitor, in combination with cetuximab in refractory solid tumors and KRAS mutant colorectal cancer. Invest New Drugs 34:168-75
Wisinski, Kari B; Cantu, Colby A; Eickhoff, Jens et al. (2015) Potential cytochrome P-450 drug-drug interactions in adults with metastatic solid tumors and effect on eligibility for Phase I clinical trials. Am J Health Syst Pharm 72:958-65
LoConte, Noelle K; Razak, Albiruni R A; Ivy, Percy et al. (2015) A multicenter phase 1 study of ? -secretase inhibitor RO4929097 in combination with capecitabine in refractory solid tumors. Invest New Drugs 33:169-76
Deming, Dustin A; Ninan, Jacob; Bailey, Howard H et al. (2014) A Phase I study of intermittently dosed vorinostat in combination with bortezomib in patients with advanced solid tumors. Invest New Drugs 32:323-9
Schelman, William R; Mohammed, Tabraiz A; Traynor, Anne M et al. (2014) A phase I study of AT-101 with cisplatin and etoposide in patients with advanced solid tumors with an expanded cohort in extensive-stage small cell lung cancer. Invest New Drugs 32:295-302
Bruce, Justine Yang; Kolesar, Jill M; Hammers, Hans et al. (2014) A phase I pharmacodynamic trial of sequential sunitinib with bevacizumab in patients with renal cell carcinoma and other advanced solid malignancies. Cancer Chemother Pharmacol 73:485-93

Showing the most recent 10 out of 52 publications