Metastatic MelanomaPhase 1/2NCT00597038
A Phase I/II Study of Dasatinib and Dacarbazine
A Phase 1/2 study testing Dasatinib and Dacarbazine (DTIC) in people with Metastatic Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
The purpose of this study is to: Phase I Objectives: Find the most tolerated dose to use for Phase II Collect information on how the body responds to this combination of study drug Phase II Objectives: To determine the overall response of participants using this combination of study drug The expression of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Dasatinib and Dacarbazine (DTIC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Sep 2011
- Phase
- Phase 1/2
- 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 or cytologically proven melanoma with Stage IV or unresectable stage III disease
- Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade ≤1.
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin ≤1.5 x ULN
- Absolute neutrophil count (ANC) ≥1500/µL
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- Platelets ≥100,000/µL
- Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated)
- Serum calcium ≤12.0 mg/dL
- Serum creatinine ≤1.5 x ULN
- Patients with CNS metastasis must have had either; a) resected central nervous system (CNS) metastasis without evidence of recurrence for >12 weeks; b) Brain metastasis treated by stereotactic radiosurgery without evidence of recurrence or progression for 12 weeks; Or, c) Multiple brain lesions treated with whole-brain radiation therapy (WBRT) with stable disease off corticosteroids for at least 12 weeks prior to start of therapy; and, d)Without any evidence of leptomeningeal disease. Patients must be neurologically intact.
- May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2 or GM-CSF
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria is required in the Phase II portion of the trial. In the phase I part of the trial patients with evaluable but not measurable disease may be allowed with the permission of the Principal Investigator (PI)
- Eastern Cooperative Oncology Group (ECOG) PS 0-2
Who cannot join
- Major surgery or radiation therapy within 4 weeks of starting the study treatment.
- NCI CTCAE grade 2 or greater hemorrhage within 4 weeks of starting the study treatment.
- History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
- QTc >470 msec on baseline EKG.
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- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
- Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg orally (po) daily for thromboembolism prophylaxis is allowed).
- Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
- May not have had previous treatment with a Dacarbazine (DTIC) or temozolomide based chemotherapy regimen. In the Phase II part of the trial patients may not have had treatment with any chemotherapy regimen
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco
San Francisco, California, 94115
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I/II Study of Dasatinib and Dacarbazine in Patients With Metastatic Melanoma
The purpose of this study is to:
Phase I Objectives:
Read more
- Find the most tolerated dose to use for Phase II
- Collect information on how the body responds to this combination of study drug
Phase II Objectives:
- To determine the overall response of participants using this combination of study drug
The expression of proto-oncogene tyrosine-protein kinase (Src), a substance present in a significant proportion of melanomas plays a role in the growth, multiplying, and dividing of cancer cells. Melanoma cells appear to be sensitive to these agents that block the action of Src in concentrations that can be achieved in patients. We suggest that Src inhibitors (such as Dasatinib) may be a good choice for treatment of melanoma in combination with Dacarbazine (a chemotherapy drug that can cause the shrinkage of melanomas). We wish to to evaluate the Src inhibitor Dasatinib in combination with the chemotherapy drug Dacarbazine. The novel oral Src inhibitor Dasatinib may be able to increase the effectiveness of chemotherapy for melanoma compared to chemotherapy alone. Dacarbazine is a standard treatment for melanoma currently. The effectiveness of this chemotherapy drug may be increased by combination with Dasatinib. Dacarbazine has been approved by the US Food and Drug Administration (FDA) for treating melanoma; Dasatinib has been approved by the FDA to treat leukemia, but it has not been approved alone or in combination with Dacarbazine to treat melanoma.
Read the detailed description
Patient will receive Dacarbazine intravenously (IV), which means it is given through a needle in a vein in the arm or through a venous port (if patient already has one). Dasatinib will be given orally starting day 2 for 17 days straight (days 2 through 19) starting the day after patient receives their first dose of Dacarbazine. The therapy will be repeated every 21 days (21 days = 1 cycle). Patient may be given other drugs before each cycle to help reduce side effects of the therapy. If patient experiences severe side effects, the amount of Dacarbazine and/or Dasatinib they receive in future cycles may be decreased.
Cycle 1 day 1:
- Dacarbazine Intravenous
- Toxicity assessment - evaluation of any side effects that patient may be experiencing
- Medical history*
- Physical examination* - measure height, weight, blood pressure, pulse, breathing rate, temperature, assessment of patient's energy and activity level (Eastern Cooperative Group [ECOG] Performance Status)
- Blood tests (3 tablespoons) for safety tests*- Complete blood count with differential and platelets (CBC), Comprehensive metabolic profile (CMP), \& Magnesium test *(certain tests may not need to be performed if they were performed during screening within 1 week; study doctor will tell patient if they need to have these tests redone)
Cycle 1 day 8:
- Toxicity assessment - (these will be done for the first cycle of treatment, but will be discontinued for later cycles unless deemed necessary by study doctor)
- CBC - (1 tablespoon) (this will be done for the first cycle of treatment, but will be discontinued for later cycles unless deemed necessary by study doctor)
- Dasatinib orally
Cycle 1 day 15:
- Toxicity assessment - (these will be done for the first cycle of treatment, but will be discontinued for later cycles unless deemed necessary by study doctor)
- CBC - (1 tablespoon) these will be done for the first cycle of treatment, but will be discontinued for later cycles unless deemed necessary by study doctor)
- Dasatinib orally
- Blood sample for pharmacokinetic (PK) analysis
Patient will also take Dasatinib orally as instructed days: 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 16, 17, 18, 19 each cycle.
Day 1 for all cycles after the first cycle:
- Dacarbazine Intravenous (IV)
- Dasatinib orally
- Medical history
- Physical examination: measure height, weight, blood pressure, pulse, breathing rate, temperature, assessment of patient's energy and activity level (ECOG Performance Status)
- Blood tests (2 tablespoon) for safety tests: CMP \& CBC
- An electrocardiogram (EKG)
- Computed tomography (CT) scan (done every other cycle starting with cycle 2)
- Toxicity assessment
If patient decides not to continue participation in this study or is taken off the study by their study doctor or the sponsor they will return to the clinic for one more visit.
During this visit the following procedures will be performed:
- Medical history
- Perform a physical examination: measure height, weight, blood pressure, pulse, breathing rate, temperature, assessment of patient's energy and activity level (Eastern Cooperative Group [ECOG] Performance Status)
- Blood tests (2 tablespoons) for safety tests: CBC \& CMP
- Toxicity assessment Patient will need to take their assigned Dasatinib dose twice daily. It may be taken with or without food.
- Conditions
- Metastatic Melanoma
- Being tested
- Dasatinib and Dacarbazine (DTIC)
- Keywords
- Dasatinib, Dacarbazine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib and Dacarbazine (DTIC)Drug
Also called Sprycel (Dasatinib), DTIC (Dacarbazine)
Arm A/ Phase I Potential Dose Levels.
Dose Level -1: Dasatinib 40 mg; DTIC 600 mg/m^2. Dose Level 1: Dasatinib 50 mg; DTIC 800 mg/m^2. Dose Level 2: Dasatinib 70 mg; DTIC 800 mg/m^2. Dose Level 3: Dasatinib 70 mg; DTIC 1000 mg/m^2.
Arm B/Phase II Potential Dose Levels.
MTD1: Dasatinib 70 mg; DTIC 1000 mg/m^2. MTD2: Dasatinib 70 mg; DTIC 800 mg/m^2. MTD3: Dasatinib 100 mg: DTIC 1000 mg/m^2.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose Escalation | Experimental | Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established. Receives: Drug: Dasatinib and Dacarbazine (DTIC) |
| Phase II Dose Treatment | Experimental | Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2. Receives: Drug: Dasatinib and Dacarbazine (DTIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose
To determine the maximum tolerated dose of dasatinib twice a day when given with dacarbazine. Adverse events were graded using Common Terminology Criteria for Adverse Events version 3.0. Dose-limiting toxicities are defined as any grade 4 haematological toxicity (except asymptomatic grade 4 neutropenia for =/< 7 days); prolonged grade 3 or 4 thrombocytopenia (47 days) or thrombocytopenia associated with bleeding, requiring platelet transfusion; any grade 3 or 4 nonhaematological toxicity despite optimal supportive care; any toxicity considered unacceptable by the study principal investigator.
Measured: 1 Year 3 Months
Phase II - Number of Participants With Overall Response (OR)
Phase II - To determine the overall response rate (ORR) of the combination of dasatinib and DTIC by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved.
Measured: 1 Year 6 Months
Secondary outcomes (2)
Number of Participants With Progression Free Survival (PFS) at 6 Months
Phase II - PFS Rate in patients receiving dasatinib 70 mg orally (PO) twice a day (BID). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved. Stable disease was defined as maintenance of the sum of lesions diameters between a 30% reduction and a 20% increase of overall tumour size over 12 weeks or longer.
Measured: 6 Months
Number of Participants With 12 Month Overall Survival (OS)
Phase II - To determine Overall Survival of patients treated with the combination of dasatinib and DTIC at 12 months.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2011
- Study completionSep 2011
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 Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Jeffrey Weber, M.D.. Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research InstituteAdil Daud, M.D., Study chair, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597038
- Sponsor's protocol ID
- MCC-15256
- Other IDs
- 106128, CA180-092
- Status last verified
- May 2012
- First submitted
- 8 Jan 2008
- Last updated
- 16 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Dasatinib and Dacarbazine in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00597038
- Acronym / sponsor ID
- MCC-15256
- Conditions
- Metastatic Melanoma
- Keywords
- Dasatinib, Dacarbazine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Posted 26 Jun 2012
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:
Phase I Objectives:
- Find the most tolerated dose to use for Phase II
- Collect information on how the body responds to this combination of study drug
Phase II Objectives:
- To determine the overall response of participants using this combination of study drug
The expression of proto-oncogene tyrosine-protein kinase (Src), a substance present in a significant proportion of melanomas plays a role in the growth, multiplying, and dividing of cancer cells. Melanoma cells appear to be sensitive to these agents that block the action of Src in concentrations that can be achieved in patients. We suggest that Src inhibitors (such as Dasatinib) may be a good choice for treatment of melanoma in combination with Dacarbazine (a chemotherapy drug that can cause the shrinkage of melanomas). We wish to to evaluate the Src inhibitor Dasatinib in combination with the chemotherapy drug Dacarbazine. The novel oral Src inhibitor Dasatinib may be able to increase the effectiveness of chemotherapy for melanoma compared to chemotherapy alone. Dacarbazine is a standard treatment for melanoma currently. The effectiveness of this chemotherapy drug may be increased by combination with Dasatinib. Dacarbazine has been approved by the US Food and Drug Administration (FDA) for treating melanoma; Dasatinib has been approved by the FDA to treat leukemia, but it has not been approved alone or in combination with Dacarbazine to treat melanoma.
Detailed description
Patient will receive Dacarbazine intravenously (IV), which means it is given through a needle in a vein in the arm or through a venous port (if patient already has one). Dasatinib will be given orally starting day 2 for 17 days straight (days 2 through 19) starting the day after patient receives their first dose of Dacarbazine. The therapy will be repeated every 21 days (21 days = 1 cycle). Patient may be given other drugs before each cycle to help reduce side effects of the therapy. If patient experiences severe side effects, the amount of Dacarbazine and/or Dasatinib they receive in future cycles may be decreased.
Cycle 1 day 1:
- Dacarbazine Intravenous
- Toxicity assessment - evaluation of any side effects that patient may be experiencing
- Medical history*
- Physical examination* - measure height, weight, blood pressure, pulse, breathing rate, temperature, assessment of patient's energy and activity level (Eastern Cooperative Group [ECOG] Performance Status)
- Blood tests (3 tablespoons) for safety tests*- Complete blood count with differential and platelets (CBC), Comprehensive metabolic profile (CMP), \& Magnesium test *(certain tests may not need to be performed if they were performed during screening within 1 week; study doctor will tell patient if they need to have these tests redone)
Cycle 1 day 8:
- Toxicity assessment - (these will be done for the first cycle of treatment, but will be discontinued for later cycles unless deemed necessary by study doctor)
- CBC - (1 tablespoon) (this will be done for the first cycle of treatment, but will be discontinued for later cycles unless deemed necessary by study doctor)
- Dasatinib orally
Cycle 1 day 15:
- Toxicity assessment - (these will be done for the first cycle of treatment, but will be discontinued for later cycles unless deemed necessary by study doctor)
- CBC - (1 tablespoon) these will be done for the first cycle of treatment, but will be discontinued for later cycles unless deemed necessary by study doctor)
- Dasatinib orally
- Blood sample for pharmacokinetic (PK) analysis
Patient will also take Dasatinib orally as instructed days: 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 16, 17, 18, 19 each cycle.
Day 1 for all cycles after the first cycle:
- Dacarbazine Intravenous (IV)
- Dasatinib orally
- Medical history
- Physical examination: measure height, weight, blood pressure, pulse, breathing rate, temperature, assessment of patient's energy and activity level (ECOG Performance Status)
- Blood tests (2 tablespoon) for safety tests: CMP \& CBC
- An electrocardiogram (EKG)
- Computed tomography (CT) scan (done every other cycle starting with cycle 2)
- Toxicity assessment
If patient decides not to continue participation in this study or is taken off the study by their study doctor or the sponsor they will return to the clinic for one more visit.
During this visit the following procedures will be performed:
- Medical history
- Perform a physical examination: measure height, weight, blood pressure, pulse, breathing rate, temperature, assessment of patient's energy and activity level (Eastern Cooperative Group [ECOG] Performance Status)
- Blood tests (2 tablespoons) for safety tests: CBC \& CMP
- Toxicity assessment Patient will need to take their assigned Dasatinib dose twice daily. It may be taken with or without food.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Escalation | Experimental | Drug: Dasatinib and Dacarbazine (DTIC)Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established. |
| Phase II Dose Treatment | Experimental | Drug: Dasatinib and Dacarbazine (DTIC)Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically proven melanoma with Stage IV or unresectable stage III disease
- Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade ≤1.
- Adequate organ function as defined by the following criteria:
- Patients with CNS metastasis must have had either; a) resected central nervous system (CNS) metastasis without evidence of recurrence for >12 weeks; b) Brain metastasis treated by stereotactic radiosurgery without evidence of recurrence or progression for 12 weeks; Or, c) Multiple brain lesions treated with whole-brain radiation therapy (WBRT) with stable disease off corticosteroids for at least 12 weeks prior to start of therapy; and, d)Without any evidence of leptomeningeal disease. Patients must be neurologically intact.
- May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2 or GM-CSF
Key exclusion criteria (12 listed)
- Major surgery or radiation therapy within 4 weeks of starting the study treatment.
- NCI CTCAE grade 2 or greater hemorrhage within 4 weeks of starting the study treatment.
- History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
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 |
|---|---|---|
| Dasatinib and Dacarbazine (DTIC)Also: Sprycel (Dasatinib), DTIC (Dacarbazine)Arm A/ Phase I Potential Dose Levels. Dose Level -1: Dasatinib 40 mg; DTIC 600 mg/m^2. Dose Level 1: Dasatinib 50 mg; DTIC 800 mg/m^2. Dose Level 2: Dasatinib 70 mg; DTIC 800 mg/m^2. Dose Level 3: Dasatinib 70 mg; DTIC 1000 mg/m^2. Arm B/Phase II Potential Dose Levels. MTD1: Dasatinib 70 mg; DTIC 1000 mg/m^2. MTD2: Dasatinib 70 mg; DTIC 800 mg/m^2. MTD3: Dasatinib 100 mg: DTIC 1000 mg/m^2. | Drug | Phase I Dose Escalation, Phase II Dose Treatment |
Primary outcome
Recommended Phase II Dose
Time frame: 1 Year 3 Months
To determine the maximum tolerated dose of dasatinib twice a day when given with dacarbazine. Adverse events were graded using Common Terminology Criteria for Adverse Events version 3.0. Dose-limiting toxicities are defined as any grade 4 haematological toxicity (except asymptomatic grade 4 neutropenia for =/< 7 days); prolonged grade 3 or 4 thrombocytopenia (47 days) or thrombocytopenia associated with bleeding, requiring platelet transfusion; any grade 3 or 4 nonhaematological toxicity despite optimal supportive care; any toxicity considered unacceptable by the study principal investigator.
Phase II - Number of Participants With Overall Response (OR)
Time frame: 1 Year 6 Months
Phase II - To determine the overall response rate (ORR) of the combination of dasatinib and DTIC by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved.
2 secondary outcomes
Number of Participants With Progression Free Survival (PFS) at 6 Months
Time frame: 6 Months
Number of Participants With 12 Month Overall Survival (OS)
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- 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.
Jeffrey Weber, M.D.. Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
Adil Daud, M.D. study chair
Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco
2 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 Dasatinib and Dacarbazine (DTIC) in people with Metastatic Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 14 inclusion and 12 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 16 Dec 2013. 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 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?
Yes. Results are posted in the registry (first posted 26 Jun 2012). 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?
Recommended Phase II Dose (time frame: 1 Year 3 Months). 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 16 Dec 2013.