Prostate CancerPhase 2NRRNCT00246753
Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase 2 study testing lapatinib ditosylate in people with Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with prostate cancer that did not respond to hormone therapy. 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?
- lapatinib ditosylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2005to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients must have histologically confirmed diagnosis of adenocarcinoma of the prostate.
- On androgen deprivation therapy for prostate cancer (either bilateral orchiectomy or medical castration with the testosterone level of <50 ng/dl)
- Biochemical progression on androgen deprivation therapy with minimum PSA of 5 ng/ml. Progression is defined as two successive rises in PSA, measured at least one week apart. See section 4.1 for additional criteria.
- Minimum of 4-6 weeks off anti-androgen therapy (4 weeks for flutamide, 6 weeks for bicalutamide and nilutamide).
- Minimum of 4 weeks off other hormonal therapy (i.e. ketoconazole, megestrol acetate, aminoglutethimide)
- Minimum of 4 weeks from any prior radiation therapy, surgery, chemotherapy or other investigational agent.
Show all 15Show fewer
- Patients must discontinue use of any herbal supplements prior to study initiation.
- No prior or concurrent exposure to cytotoxic chemotherapy.
- Age > 18 years.
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or multigated acquisition scan (MUGA) scan.
- Men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation since the effects of GW572016 on the developing human fetus at the recommended therapeutic dose are unknown.
- Ability to swallow and retain oral medication.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had prior treatment with ErbB family targeting therapies.
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Prior chemotherapy for prostate cancer
- Patients with known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Show all 9Show fewer
- A history of a positive HIV test in the past.
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors (please refer to section 3.2.2 for a list of medications).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, 27607
About this study
Official title: A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with prostate cancer that did not respond to hormone therapy.
Read the detailed description
OBJECTIVES:
Primary
- Determine the proportion of patients with hormone-refractory prostate cancer who experience > 50% decline in prostate-specific antigen (PSA) after treatment with lapatinib ditosylate.
Secondary
- Determine the safety of this drug in these patients.
- Determine the time to PSA progression in patients treated with this drug.
- Determine the molecular correlates and predictive biomarkers of response in patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral lapatinib ditosylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Serum samples are collected for biomarker analysis at baseline and every 4 weeks.
After completion of study treatment, patients are followed at 4 weeks.
- Conditions
- Prostate Cancer
- Being tested
- lapatinib ditosylate
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinib ditosylateDrug
Also called GW572016
1500 mg, daily until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Trial | Other | Single Arm Trial where each patient receives GW572016 (lapatinib ditosylate) at a dose of 1500mg daily initially until disease progression or unacceptable toxicity. Receives: Drug: lapatinib ditosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Experiencing Decline in Prostate-specific Antigen
Determine the number of patients with hormone-refractory prostate cancer who experience > 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.
Measured: 4 years
Secondary outcomes (2)
Time to Prostate-Specific Antigen (PSA) Progression
Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.
Measured: 4 years
Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)
To assess the correlation between expression of molecular markers and patient response to treatment with GW572016
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJul 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Young Whang, MD, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246753
- Sponsor's protocol ID
- LCCC 0505
- Other IDs
- CDR0000550151
- Acronym
- NRR
- Status last verified
- May 2017
- First submitted
- 28 Oct 2005
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00246753
- Acronym / sponsor ID
- NRR / LCCC 0505
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 2005
- Primary completion
- Jul 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with prostate cancer that did not respond to hormone therapy.
Detailed description
OBJECTIVES:
Primary
- Determine the proportion of patients with hormone-refractory prostate cancer who experience > 50% decline in prostate-specific antigen (PSA) after treatment with lapatinib ditosylate.
Secondary
- Determine the safety of this drug in these patients.
- Determine the time to PSA progression in patients treated with this drug.
- Determine the molecular correlates and predictive biomarkers of response in patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral lapatinib ditosylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Serum samples are collected for biomarker analysis at baseline and every 4 weeks.
After completion of study treatment, patients are followed at 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Trial | Other | Drug: lapatinib ditosylateSingle Arm Trial where each patient receives GW572016 (lapatinib ditosylate) at a dose of 1500mg daily initially until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically confirmed diagnosis of adenocarcinoma of the prostate.
- On androgen deprivation therapy for prostate cancer (either bilateral orchiectomy or medical castration with the testosterone level of <50 ng/dl)
- Biochemical progression on androgen deprivation therapy with minimum PSA of 5 ng/ml. Progression is defined as two successive rises in PSA, measured at least one week apart. See section 4.1 for additional criteria.
- Minimum of 4-6 weeks off anti-androgen therapy (4 weeks for flutamide, 6 weeks for bicalutamide and nilutamide).
- Minimum of 4 weeks off other hormonal therapy (i.e. ketoconazole, megestrol acetate, aminoglutethimide)
Key exclusion criteria (9 listed)
- Patients who have had prior treatment with ErbB family targeting therapies.
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Prior chemotherapy for prostate cancer
- Patients with known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.
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 |
|---|---|---|
| lapatinib ditosylateAlso: GW5720161500 mg, daily until disease progression | Drug | Single Arm Trial |
Primary outcome
Number of Patients Experiencing Decline in Prostate-specific Antigen
Time frame: 4 years
Determine the number of patients with hormone-refractory prostate cancer who experience > 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.
2 secondary outcomes
Time to Prostate-Specific Antigen (PSA) Progression
Time frame: 4 years
Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Young Whang, MD, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lapatinib ditosylate in people with Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 3 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?
The sponsor lists 15 inclusion and 9 exclusion criteria. 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Experiencing Decline in Prostate-specific Antigen (time frame: 4 years). 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 28 Jun 2017.