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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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-naìˆve

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles.

Outcome Time Frame:

Treatment period

Safety Issue:

Yes

Principal Investigator

Dwight Stickney, MD

Investigator Role:

Study Director

Investigator Affiliation:

Harbor Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

HE3235-0201

NCT ID:

NCT00716794

Start Date:

July 2008

Completion Date:

March 2011

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • HE3235
  • Apoptone
  • Prostatic Neoplasms

Name

Location

Phoenix, Arizona  85012
Fountain Valley, California  92708
Albany, New York  12208
Austin, Texas  78705
Seattle, Washington  98195
Charlotte, North Carolina