Prostate Cancer
Conditions
Keywords
Prostate cancer, HE3235, Apoptone
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.
Interventions
DRUGHE3235
HE3235 will be administered orally in 28 day cycles.
Sponsors
Harbor Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed