A Phase I/II, Open-Label, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Activity of HE3235 When Administered Orally to Patients With Prostate Cancer

Main

Inclusion Criteria:

- Patient is male and at least 18 years of age, at the time of screening;

- Patient has metastatic disease (any T, any N, M1);

- Patient has failed at least 1 taxane regimen; or Patient has symptomatic or
asymptomatic CRPC and is chemotherapy-naïve

- Patient has histologically or cytologically confirmed adenocarcinoma of the prostate;

- Patient has progression of disease despite adequate hormone therapy, demonstrated by
one of the following:

- PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions,
at least 1 week apart.

- Evaluable disease progression by modified RECIST (Response Evaluation Criteria
in Solid Tumors) criteria;

- Progression of metastatic bone disease on bone scan with > 2 new lesions

- Patient has ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;

Main Exclusion Criteria:

- Patient has symptomatic parenchymal brain metastases or active epidural disease
requiring whole-brain irradiation Treated epidural disease is allowed

- Patient has active infection;

- Patient having a history of clinically significant cardiovascular disease (such as
CHF), clinically significant hepatic, respiratory or renal abnormalities;

- Patient who has any clinically significant abnormalities in laboratory results at
screening

- Patient who has a history of clinically significant neurological or psychiatric
condition;

Additional criteria are applicable to expansion cohorts.