A Phase I/II Study of HE3235 in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is a phase I/II, open-label, dose escalation study of HE3235 administered orally to patients with advanced prostate cancer who have failed hormone therapy and at least one taxane based chemotherapy regimen.

Official Title
-----------------
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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: HE3235


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HE3235|HE3235 will be administered orally in 28 day cycles.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles. |  | Treatment period | 
| To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing. |  | Treatment period | 
| To assess potential activity of HE3235 in prostate cancer patients. |  | Treatment period and post-study follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore circulating tumor cell (CTC) enumeration in response to treatment as a marker evaluating whether an investigational therapy is effective for tumor treatment |  | Treatment period | 
| Evaluate the role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response. |  | Treament period and post-study follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, HE3235, Apoptone