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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716794
• Other study ID #: HE3235-0201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 14, 2008
• Last updated: March 8, 2011
• Start date: July 2008
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Harbor Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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-nai¨ve

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• HE3235
HE3235 will be administered orally in 28 day cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Harbor Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles.		Treatment period	Yes
Primary	To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing.		Treatment period	No
Primary	To assess potential activity of HE3235 in prostate cancer patients.		Treatment period and post-study follow-up period	No
Secondary	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	No
Secondary	Evaluate the role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response.		Treament period and post-study follow-up	No