• Patient Selection
• Trial Initiation
• Dosing and Treatment Schedules
  • Microdosing/phase 0 clinical trials
  • Personalized dosing
• Informed Consent and Patient Recruitment
• Phase I Clinical Trial Reporting
• Decision to Advance Development of Agents Based on Phase I Clinical Trials
• Benefits of Phase I Monotherapy in Oncology

NOVEL ANTICANCER AGENTS/FORMULATIONS IN PHASE I MONOTHERAPY TRIALS

• Cytotoxic Agents, Targeted Cytotoxics, Apoptosis Inducters, and Immunoconjugates
• AQ4N
• C-1311
• CHR-2797
• CMC-544
• CYC682
• DOXO-EMCH
• DTS-201
• FFC11
• FFC14A
• KOS-1584
• IPdR
• MPC-2130
• MPC-6827
• MST-997
• SB-743921
• SR271425
• XR5944
• Hormone Modulators
• CC-8490
• Histone Deacetylase Inhibitors (HDAC)
• CRA-023781
• LBH589
• MGCD0103
• Regulatory/Targeted Agents, Cell-Cycle Modulators, Angiogenesis Inhibitors, and Vascular Targeting Agents (VTA)
  • AEE788
  • AS1411
  • ATN-224
  • AVE8062A
  • AZD0530
  • BAY 57-9352
  • BMS-599626
  • CTCE-9908
  • CX-3543
  • E7820
  • GRN163L
  • HGS-ETR2
  • KRN951
  • LErafAON-ETU
  • ON01910.Na
  • OXi4503
  • RAV12
  • SNS-595
  • SU014813
  • ZK-304709
• Immunotherapy/Vaccines
  • GI-4000
  • IGN311
  • Interleukin-21 (IL-21)
  • KW-2871
  • Phosphostim
  • PSMA-based vaccine
  • RNA-loaded autologous dendritic cell (DC) vaccine
  • VX-001

Exhibit 1 - Phase I Clinical Trial Terminology

Exhibit 2 - Overall Responses in Phase I Clinical Trials

Exhibit 3 - Responses in Monotherapy Phase I Clinical Trials

Exhibit 4 - Anticancer Agents in Phase I Monotherapy Clinical Trials with Recently Reported Preclinical or Clinical Findings

Exhibit 5 - Responses in Phase I Clinical Trials Involving Regulatory/Antiangiogenesis Agents

Exhibit 6 - Molecular Targets of Drugs in Phase I Clinical Trials

Exhibit 7 - Responses in Phase I Clinical Trials Involving Immunomodulators/Vaccines