Recurrent MelanomaPhase 2NCT00436605
Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma
A Phase 2 study testing dasatinib in people with Recurrent Melanoma and Stage IIIA Melanoma, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma
- What is being tested?
- dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2006to Nov 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed stage III unresectable or stage IV melanoma
- Measurable disease
- Must have evidence of tumor growth or new lesions within the past 6 months
- No large pleural effusions
- No known brain metastases or leptomeningeal metastases
- Previously treated brain metastases allowed provided there is no requirement for steroids AND no evidence of progression for ≥ 8 weeks after treatment
Show all 59Show fewer
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Life expectancy > 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
- Bilirubin ≤ 1.5 mg/mL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- PT/INR and PTT normal
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- No medical condition that may affect the ability to swallow and retain dasatinib tablets, including any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication
- Requirement for IV alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
- No clinically significant cardiovascular disease, including any of the following:
- Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- Prolonged QTc > 480 msec
- Major conduction abnormality (unless a cardiac pacemaker is present)
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- History of significant congenital or acquired bleeding disorder, including any of the following:
- Von Willebrand's disease
- Antifactor VIII antibodies
- Dyspnea at rest or with minimal exertion
- Uncontrolled seizure disorder
- Psychiatric illness or social situations that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active malignancy within the past 3 years except curatively treated stage I malignancies or resected skin carcinomas
- Recovered from prior therapy
- Prior adjuvant therapy for stage II or III melanoma allowed
- No prior cytotoxic therapy for metastatic melanoma
- No prior dasatinib or other inhibitors of src, bcr-abl, c-Kit, EPHA2, and PDGFRβ
- No more than 2 prior immunomodulator therapies for metastatic melanoma
- At least 1 week since prior and no concurrent warfarin or other anticoagulants or medications that inhibit platelet function (including acetylsalicylic acid)
- At least 1 week since prior and no concurrent steroids or other immunosuppressive agents
- Concurrent steroids to treat induced pleural effusions allowed
- At least 3 weeks since prior immunomodulators including, but not limited to, any of the following:
- Aldesleukin
- Cancer vaccines
- T-cell-activating monoclonal antibodies
- At least 4 weeks since prior radiotherapy
- Prior palliative radiotherapy to a single site of disease allowed (tumor is not considered evaluable for response unless there is tumor progression at the site of radiation)
- More than 7 days since prior and no concurrent CYP3A4 inhibitors
- At least 7 days since prior and no concurrent agents with proarrhythmic potential
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- No concurrent enzyme-inducing anticonvulsant agents
- No concurrent grapefruit or grapefruit juice
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent CYP3A4 inducers
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Yale University
New Haven, Connecticut, 06520
About this study
Official title: A Phase 2 Study of Dasatinib in Advanced Melanoma
This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib.
II. Determine the progression-free survival of patients treated with this drug.
SECONDARY OBJECTIVES:
- To assess the expression of targets of Dasatinib prior to treatment by obtaining pre-treatment biopsies or examining paraffin-embedded tissues from previous tumor resections.
II. In selected patients (approximately 5-10) where tumor tissue is available pre-treatment and can be obtained post-treatment with Dasatinib (21 days after initiation of therapy), to determine if Dasatinib induces changes in expression of selected targets and downstream mediators, including MEK, ERK and RSK-1.
III. To assess toxicity.
OUTLINE:
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
- Conditions
- Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma
- Being tested
- dasatinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dasatinibDrug
Also called BMS-354825, Sprycel
| Study group | Role | What they receive |
|---|---|---|
| Treatment (kinase inhibitor therapy) | Experimental | Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria
Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.
Measured: After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
Progression-free Survival
Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon's optimum two-stage design will be used
Measured: Time from start treatment to time of progression, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionMar 2010
- Study completionNov 2010
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 Recurrent MelanomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Harriet Kluger, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436605
- Sponsor's protocol ID
- NCI-2009-00219
- Other IDs
- NCI-2009-00219, CDR0000528937, UMN-2007UC009, YALE-HIC-0608001765, HIC#0608001765, 7758, P30CA016359
- Status last verified
- Oct 2011
- First submitted
- 15 Feb 2007
- Last updated
- 15 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Dasatinib in Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00436605
- Acronym / sponsor ID
- NCI-2009-00219
- Conditions
- Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Posted 20 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib.
II. Determine the progression-free survival of patients treated with this drug.
SECONDARY OBJECTIVES:
- To assess the expression of targets of Dasatinib prior to treatment by obtaining pre-treatment biopsies or examining paraffin-embedded tissues from previous tumor resections.
II. In selected patients (approximately 5-10) where tumor tissue is available pre-treatment and can be obtained post-treatment with Dasatinib (21 days after initiation of therapy), to determine if Dasatinib induces changes in expression of selected targets and downstream mediators, including MEK, ERK and RSK-1.
III. To assess toxicity.
OUTLINE:
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 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 |
|---|---|---|
| Treatment (kinase inhibitor therapy) | Experimental | Drug: dasatinibPatients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (59 listed)
- Histologically confirmed stage III unresectable or stage IV melanoma
- Measurable disease
- Must have evidence of tumor growth or new lesions within the past 6 months
- No large pleural effusions
- No known brain metastases or leptomeningeal metastases
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| dasatinibAlso: BMS-354825, Sprycel | Drug | Treatment (kinase inhibitor therapy) |
Primary outcome
Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria
Time frame: After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.
Progression-free Survival
Time frame: Time from start treatment to time of progression, assessed up to 6 months
Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon's optimum two-stage design will be used
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Harriet Kluger principal investigator
Yale University
2 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 dasatinib in people with Recurrent Melanoma and Stage IIIA Melanoma, run by National Cancer Institute (NCI) at 2 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 59 inclusion and 0 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 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 20 Jan 2014). 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 Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria (time frame: After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment). The study lists 2 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 15 May 2014.