Prostate CancerPhase 1/2NCT00716794
A Phase I/II Study of HE3235 in Patients With Prostate Cancer
A Phase 1/2 study testing HE3235 in people with Prostate Cancer, run by Harbor Therapeutics at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HE3235
- Type of treatment
- Pill or oral medicine
- How many people
- 64 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2008to Mar 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Charlotte, North Carolina, 28204
Study site
Encinitas, California, 92024
Study site
New York, New York, 10065
Study site
Roseville, California, 95661
Study site
San Antonio, Texas, 78229
Study site
San Francisco, California, 94115
Study site
Scottsdale, Arizona, 85260
Study site
Seattle, Washington, 98109
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- HE3235
- Keywords
- Prostate cancer, HE3235, Apoptone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HE3235Drug
Also called Apoptone
HE3235 will be administered orally in 28 day cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles.
Measured: Treatment period
To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing.
Measured: Treatment period
To assess potential activity of HE3235 in prostate cancer patients.
Measured: Treatment period and post-study follow-up period
Secondary outcomes (2)
Explore circulating tumor cell (CTC) enumeration in response to treatment as a marker evaluating whether an investigational therapy is effective for tumor treatment
Measured: Treatment period
Evaluate the role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response.
Measured: Treament period and post-study follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbor Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dwight Stickney, MD, Study director, Harbor Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716794
- Sponsor's protocol ID
- HE3235-0201
- Status last verified
- Mar 2011
- First submitted
- 14 Jul 2008
- Last updated
- 9 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00716794
- Acronym / sponsor ID
- HE3235-0201
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, HE3235, Apoptone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Harbor TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HE3235Also: ApoptoneHE3235 will be administered orally in 28 day cycles. | Drug | – |
Primary outcome
To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles.
Time frame: Treatment period
To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing.
Time frame: Treatment period
To assess potential activity of HE3235 in prostate cancer patients.
Time frame: Treatment period and post-study follow-up period
2 secondary outcomes
Explore circulating tumor cell (CTC) enumeration in response to treatment as a marker evaluating whether an investigational therapy is effective for tumor treatment
Time frame: Treatment period
Evaluate the role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response.
Time frame: Treament period and post-study follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dwight Stickney, MD study director
Harbor Therapeutics
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HE3235 in people with Prostate Cancer, run by Harbor Therapeutics at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles. (time frame: Treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2011; AzTrials last refreshed its copy on 7 Nov 2026.