Status:
COMPLETED
A Phase I/II Study of HE3235 in Patients With Prostate Cancer
Lead Sponsor:
Harbor Therapeutics
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 chemothera...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00716794
Start Date
July 1 2008
End Date
March 1 2011
Last Update
March 9 2011
Active Locations (8)
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1
Scottsdale, Arizona, United States, 85260
2
Encinitas, California, United States, 92024
3
Roseville, California, United States, 95661
4
San Francisco, California, United States, 94115