Clinical trial NCT00716794: A Phase I/II Study of HE3235 in Patients With Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
HE3235
Apoptone
Lead sponsor: Harbor Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles.
timeFrame: Treatment period
measure: To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing.
timeFrame: Treatment period
measure: To assess potential activity of HE3235 in prostate cancer patients.
timeFrame: Treatment period and post-study follow-up period
Secondary outcomes:
measure: Explore circulating tumor cell (CTC) enumeration in response to treatment as a marker evaluating whether an investigational therapy is effective for tumor treatment
timeFrame: Treatment period
measure: Evaluate the role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response.
timeFrame: Treament period and post-study follow-up
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Encinitas
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Francisco
country: United States
state: California
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: San Antonio
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Harbor Therapeutics
name: Dwight Stickney, MD
role: STUDY_DIRECTOR
References: