Malignant MelanomaPhase 2NCT00483301
A Phase II Trial OF Carboplatin, ABI-007 (Abraxane) And Sorafenib (BAY 43-9006) in Metastatic Melanoma
A Phase 2 study testing Sorafenib (BAY 43-9006) and ABI-007(Abraxane) in people with Malignant Melanoma, run by Mt. Sinai Medical Center, Miami at 2 sites in United States.
Trial summary
The purpose of this study is to compare the effects, good and/or bad, of Carboplatin and ABI-007 (Abraxane) in combination with Sorafenib (BAY 43-9006) on Melanoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Sorafenib (BAY 43-9006) and ABI-007(Abraxane)
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Aug 2009
- Phase
- Phase 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of melanoma with measurable disease
- Patients with stage IV, previously untreated, refractory to initial therapy or progressing after response to initial therapy
- Patients with unresectable stage III, including unresectable in-transit metastases
- Two prior chemotherapy regimen is allowed
- One prior immunotherapy regimen is allowed
- No other concurrent investigational therapy
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- Radiation therapy to non-target lesions or to one of multiple target lesions may be allowed on a case-by-case basis
- Patients must be past the nadir from previous cytotoxic therapy
- Age at least 18 years
- ECOG performance status 0-2
- Hemoglobin > 9.0 g/dl, absolute neutrophil count (ANC) > 1,500/mm3, platelet count > 100,000/mm3
- Total bilirubin within normal limits, ALT and AST < 2.0 x the ULN ( < 5 x ULN for patients with liver involvement), INR < 1.5 and aPTT within normal limits. Patients who receive anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care.
- Creatinine < 1.5 x ULN, serum calcium within normal limits
- Patients with stable brain metastasis who have been treated with either whole brain radiation or Gamma Knife and have been off steroids for > 4 weeks
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men and women should use adequate birth control for at least three months after the last administration of protocol drugs. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
- Ability to understand and sign a written informed consent document. All patients must have a signed informed consent before registration and initiation of therapy
Who cannot join
- Cardiac disease: Congestive heart failure > class II NYHA.
- Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- No known severe hypersensitivity or suspected allergy to sorafenib, ABI-007 or any of the excipients
- Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude progressing brain metastasis.
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- Peripheral neuropathy greater than grade II
- Serious intercurrent medical or psychiatric illness, including serious active infection
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Use of St. John's Wort or rifampin (rifampicin)
- Any condition that impairs patient's ability to swallow whole pills.
- Any malabsorption problem
- No treatment for melanoma within the previous 4 weeks.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dr. Steven O'Day
Los Angeles, California, 90025
Mt. Sinai Medical Center
Miami Beach, Florida, 33140
About this study
The purpose of this study is to compare the effects, good and/or bad, of Carboplatin and ABI-007 (Abraxane) in combination with Sorafenib (BAY 43-9006) on Melanoma.
Read the detailed description
The primary objective of this phase II multicenter trial is to:
Measure the response rate (RR) of this combination and schedule in patients with metastatic melanoma
The secondary objectives are to:
Assess the safety and toxicity of this regimen in this patient population
Determine the 1-year and median PFS of patients treated according to protocol
Determine overall survival (OS)
STUDY DESIGN
This will be a Phase II study single arm study with a two-stage design with a maximum sample size of 43 patients, 18 in the first stage and 25 in the second stage.
Study duration: A minimum yearly accrual of 10-15 patients/institution is expected. Therefore, to reach the first stage, the study will take 1.2 to 1.8 years with one institution, 0.6 to 0.9 years with 2 institutions, and 0.4 to 0.6 years with 3. If the study continues to full accrual to 43 patients, completion will take 2.9 to 4.3 years with one institution, 1.4 to 2.2 years with two and 0.96 to 1.43 years with three institutions.
- Conditions
- Malignant Melanoma
- Being tested
- Sorafenib (BAY 43-9006), ABI-007(Abraxane)
- Keywords
- Melanoma, Abraxane, Sorafenib, BAY 43-9006, Abraxis
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (BAY 43-9006)Drug
dosage
ABI-007(Abraxane)Drug
dosage
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Measure the response rate (RR) of this combination and schedule in patients with metastatic melanoma
Measured: one - two years
Secondary outcomes (1)
Secondary Objective
3.2.1 Assess the safety and toxicity of this regimen in this patient population Determine the 1-year and median PFS of patients treated according to protocol Determine overall survival (OS)
Measured: one-two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Bayer
- Responsible party
- Principal investigator, Jose Lutzky, Mt. Sinai Medical Center, Miami
- Investigators
- Jose Lutzky, Physician, Principal investigator, Mt. Sinai Medical Center Miami Beach Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483301
- Sponsor's protocol ID
- MEL0205
- Status last verified
- May 2012
- First submitted
- 30 May 2007
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial OF Carboplatin, ABI-007 (Abraxane) And Sorafenib (BAY 43-9006) in Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00483301
- Acronym / sponsor ID
- MEL0205
- Conditions
- Malignant Melanoma
- Keywords
- Melanoma, Abraxane, Sorafenib, BAY 43-9006, Abraxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mt. Sinai Medical Center, MiamiUniversity, hospital or other
- Collaborators
- Celgene Corporation, Bayer
- Study start
- May 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Jun 2007 (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.
The purpose of this study is to compare the effects, good and/or bad, of Carboplatin and ABI-007 (Abraxane) in combination with Sorafenib (BAY 43-9006) on Melanoma.
Detailed description
The primary objective of this phase II multicenter trial is to:
Measure the response rate (RR) of this combination and schedule in patients with metastatic melanoma
The secondary objectives are to:
Assess the safety and toxicity of this regimen in this patient population
Determine the 1-year and median PFS of patients treated according to protocol
Determine overall survival (OS)
STUDY DESIGN
This will be a Phase II study single arm study with a two-stage design with a maximum sample size of 43 patients, 18 in the first stage and 25 in the second stage.
Study duration: A minimum yearly accrual of 10-15 patients/institution is expected. Therefore, to reach the first stage, the study will take 1.2 to 1.8 years with one institution, 0.6 to 0.9 years with 2 institutions, and 0.4 to 0.6 years with 3. If the study continues to full accrual to 43 patients, completion will take 2.9 to 4.3 years with one institution, 1.4 to 2.2 years with two and 0.96 to 1.43 years with three institutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed diagnosis of melanoma with measurable disease
- Patients with stage IV, previously untreated, refractory to initial therapy or progressing after response to initial therapy
- Patients with unresectable stage III, including unresectable in-transit metastases
- Two prior chemotherapy regimen is allowed
- One prior immunotherapy regimen is allowed
Key exclusion criteria (19 listed)
- Cardiac disease: Congestive heart failure > class II NYHA.
- Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- No known severe hypersensitivity or suspected allergy to sorafenib, ABI-007 or any of the excipients
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 |
|---|---|---|
| Sorafenib (BAY 43-9006)dosage | Drug | – |
| ABI-007(Abraxane)dosage | Drug | – |
Primary outcome
Primary Objective
Time frame: one - two years
Measure the response rate (RR) of this combination and schedule in patients with metastatic melanoma
1 secondary outcome
Secondary Objective
Time frame: one-two years
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 3 May 2012.
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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.
Jose Lutzky, Physician principal investigator
Mt. Sinai Medical Center Miami Beach Florida
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 Sorafenib (BAY 43-9006) and ABI-007(Abraxane) in people with Malignant Melanoma, run by Mt. Sinai Medical Center, Miami 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 16 inclusion and 19 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 3 May 2012. 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?
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?
Primary Objective (time frame: one - two 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 3 May 2012.