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

Harbor Therapeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: HE3235

Study type

Interventional

Funder types

Industry

Identifiers

NCT00716794

HE3235-0201

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.