Study of CPI-100 in Patients With Advanced Tumors

Primary Objectives:

• To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-100 in
patients with advanced tumors

Secondary Objectives:

- To evaluate the pharmacokinetics (PK) of CPI-100

- To evaluate clinical response and resolution of symptoms after CPI-100 treatment

- To characterize adverse events of CPI-100 in patients with advanced cancers

Up to 7 dose levels of CPI-100 will be tested in a 3 + 3 dose escalation study design. MTD
will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or
equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as
one of the following events occurring from the intravenous injection of CPI-100 within 28
days:

- Grade 4 or greater treatment related adverse events

- Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity
(including nausea, vomiting or diarrhea lasting more than 72 hours)

Inclusion Criteria:

- Have a histologically or cytologically confirmed diagnosis of advanced solid tumor

- Have advanced or metastatic disease refractory to standard curative or palliative
therapy or contraindication to standard therapy

- Be reasonably recovered from preceding major surgery or no major surgery within 4
weeks prior to the start of Day 1 treatment

- Have a negative pregnancy test for females with child bearing age at screening and
should not be breast feeding

- Be willing to abstain from sexual activity or practice physical barrier contraception
from study entry to 6 months after the last day of treatment

Exclusion Criteria:

- Have peripheral neuropathy of Grade 3 or Grade 4 at screening

- Have peripheral sensory neuropathy of Grade 2 or greater at screening

- Have an interval from previous platinum drugs of less than 6 months and/or from
previous taxane drugs less than 3 months unless reasonably recovered from all grades
of neurotoxicity as judged by the investigator

- Have known hypersensitivity to chemotherapeutic agents

- Have a history of thrombocytopenia with complications including hemorrhage or bleeding
> Grade 2 that required medical intervention or any hemolytic condition or coagulation
disorders that would make participation unsafe

- Have unresolved toxicity from previous treatment or previous investigational agents;
excluding alopecia

- Is pregnant or breast-feeding