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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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11 March 2013 |
Main ID: |
EUCTR2009-014591-21-DE |
Date of registration:
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01/10/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma
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Scientific title:
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A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma |
Date of first enrolment:
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18/01/2010 |
Target sample size:
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800 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014591-21 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Finland
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France
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Germany
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Italy
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Netherlands
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Poland
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Spain
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: [1] Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV). [2] Have the presence of evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version1.0). [3] Are at least 18 years of age. [4] Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale (see Attachment JZAO.4). [5] Have progressed after 1 previous systemic treatment regimen containing dacarbazine or temozolomide for metastatic melanoma. [6] Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (45 days for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia). Whole-brain radiation must have been completed 90 days before starting study therapy. [7] Have adequate organ function including: • Bone Marrow Reserve: Absolute neutrophil count (ANC) = 1.5 x 10exp9/L prior to treatment, platelets = 100 x 10exp9/L, and hemoglobin = 8 g/dL (transfusions are not allowed to reach 8 g/dL prior to enrollment). • Hepatic: Bilirubin = 1.5 times the upper limit of normal (ULN). Alkaline phosphatase and transaminases (ALT and AST) =5 times ULN. • Renal: Serum creatinine at or below the ULN. No known active renal disease. [8] Have a serum albumin level = 3.0 g/dL or = 30 g/L. [9] Males and females with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug. [10] Females with child-bearing potential must have had a negative serum pregnancy test = 7 days prior to the first dose of study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: [14] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [15] Have received = 2 previous chemotherapy-containing systemic treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen [including biologic agents and vaccinationbased treatments], or treatment with a targeted agent (e.g BRAF or c- Kit inhibitor, is not counted as a prior treatment regimen for determining study eligibility, unless either was combined with a cytotoxic drug). [16] Any previous treatment with paclitaxel or a paclitaxel-containing regimen for metastatic melanoma. [17] Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with a history of a CNS metastasis previously treated with curative intent (e.g., stereotactic radiation or surgery) that have not progressed on follow-up imaging, and are not receiving corticosteroids, are eligible. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out brain metastasis. [18] Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator). [19] Have a second primary malignancy that could affect compliance with the protocol or interpretation of the results. NOTE: Patients with adequately treated carcinoma of the skin (non-melanoma) or patients with a prior history of malignancy who have been disease-free for more than 2 years are eligible. [20] Have serious preexisting medical conditions (at the investigator’s discretion). Patients with a history of myocardial infarction within 6 months or a history of New York Heart Association Class III or greater heart disease are not eligible. [21] Are receiving warfarin or medications structurally similar to warfarin (warfarin derivative or analogue). [22] Have previously completed or withdrawn from this study or any other study investigating tasisulam. [23] Have a known hypersensitivity to paclitaxel or Cremophor® EL (polyoxyethylated castor oil). [24] Are pregnant or lactating. [25] Have primary ocular or mucosal melanoma. Patients with melanoma of an unknown primary site are eligible if an appropriate work-up has been performed to rule out an ocular or mucosal primary. [26] Have received a recent (within 30 days before enrollment) or are receiving concurrent yellow fever vaccination. [27] Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb). [28] Are unable to withhold dosing of NSAIDs or PPIs for at least 72 hours before and after treatment with tasisulam.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Second line metastatic melanoma MedDRA version: 12.0
Level: LLT
Classification code 10027481
Term: Metastatic melanoma
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Intervention(s)
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Product Name: Tasisulam Sodium Product Code: LY573636 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: tasisulam sodium CAS Number: 519055-63-1 Current Sponsor code: LY573636 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-
Trade Name: Paclitaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6-
Trade Name: Paclitaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6-
Product Name: Tasisulam Sodium Product Code: LY573636 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: tasisulam sodium CAS Number: 519055-63-1 Current Sponsor code: LY573636 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-
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Primary Outcome(s)
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Secondary Objective: The secondary objectives of the study are: - to compare the following between treatment arms: • time-to-event efficacy variables, including: PFS, duration of response (DoR), deterioration in the FACT-M TOI score • objective tumor response rate • therapeutic benefit rate • measures of relative safety, including quantitative & qualitative laboratory & non-laboratory toxicities • health outcome measures - Translational Research (TR): • to evaluate the treatment-specific and treatment-independent effects of BRAF and c-Kit mutational status on measures of clinical efficacy, • to evaluate the treatment-specific effects of genetic markers, including on measures of clinical efficacy & toxicity. • to assess other exploratory biomarkers relevant to tasisulam and paclitaxel • to assess other exploratory biomarkers relevant to the disease state of melanoma • to assess the association between other exploratory biomarkers & clinical outcome.
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Main Objective: The primary objective of this study is to compare the overall survival (OS) of patients who have received one prior regimen of dacarbazine or temozolomide-based chemotherapy for metastatic malignant melanoma when treated with either tasisulam or paclitaxel.
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Primary end point(s): overall survival
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Secondary ID(s)
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H8K-MC-JZAO
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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