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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. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2004-000725-30-GB |
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Date of registration:
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23/02/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A phase II, multi-centre, open-label, uncontrolled study to evaluate the efficacy and safety of BAY 43-9006 given daily in combination with repeated 21-day cycles of dacarbazine (DTIC) chemotherapy in subjects with advanced metastatic melanoma. - N/A
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Scientific title:
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A phase II, multi-centre, open-label, uncontrolled study to evaluate the efficacy and safety of BAY 43-9006 given daily in combination with repeated 21-day cycles of dacarbazine (DTIC) chemotherapy in subjects with advanced metastatic melanoma. - N/A |
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Date of first enrolment:
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07/11/2007 |
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Target sample size:
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85 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000725-30 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable.
2. Age >/=18 years.
3. Subject has measurable and evaluable disease defined as at least one metastatic lesion that can be accurately and serially measured by CT or MRI scan as per the RECIST criteria (see Section 10.5, Appendix 5). Cutaneous lesions measuring at least 20mm in longest diameter can be considered measurable (and therefore target lesions) via color photography including a ruler.
4. Subject has biopsiable disease at baseline and is willing to provide biopsy samples, or does not have biopsiable disease at baseline.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
6. Life expectancy of at least 12 weeks.
7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements. These should be conducted at screening, within 7 days prior to the first dose of study drug:
* Haemoglobin > 9.0 g/dl.
* Absolute neutrophil count (ANC) >1,500/mm3.
* Platelet count = 100,000/mm3.
* Total bilirubin < 1.5 x ULN.
* Alanine transaminase (ALT) and aspartate transaminase (AST) * Serum creatinine < 1.5 x ULN.
8. Prothrombin time (PT) or the International Normalized Ratio of PT (PT-INR), and partial thromboplastin time (PTT) < 1.5 x ULN. Subjects who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists. For subjects 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.
9. Serum amylase and lipase must not be above the ULN at screening.
10. Signed informed consent must be obtained prior to any study specific procedures being performed, including per protocol biopsies.
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:
1. Primary ocular or mucosal melanoma (cutaneous vulval melanoma is permitted).
2. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
3. Presence of:
* Clinically evident congestive heart failure, NYHA > class 2. NYHA class II states; Patients have cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnoea or anginal pain.
* Cardiac arrhythmias requiring antiarrythmics, other than beta blockers or digoxin.
* Active coronary artery disease or ischaemia (myocardial infarction more than 6 months prior to study entry is allowed).
* Uncontrolled hypertension (> grade 2 NCI-CTCAE v3).
* Active clinically serious infections (> grade 2 NCI-CTCAE v3).
* Subjects with seizure disorder requiring medication are excluded.
* History of or suspected HIV infection, or chronic hepatitis B or C.
* Symptomatic metastatic brain or meningeal tumours unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. Also the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
* History of organ allograft.
* Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first study drug administration. Both men and women enrolled in this trial must use adequate barrier birth control measures from screening until the end of the active follow-up period of the trial. For the purposes of this study, post-menopausal will be considered to be 1 year without menses.
4. Excluded prior and concomitant therapies and medications, such as:
* Subjects who have received prior anticancer chemotherapy, or prior treatment with a Ras pathway inhibitor (including trastuzumab, EGFR inhibitors, farnesyl transferase inhibitors or MEK inhibitors), or treatment with a drug which targets VEGF (such as bevacizumab) will be excluded. Anticancer chemotherapy is defined as any agent or combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints. This includes anticancer chemotherapy given by isolated limb perfusion.Prior immunotherapy, cytokine or biological therapy is permitted, as long as there is at least 4 weeks’ recovery following the last dose of therapy prior to study entry. Prior vaccine therapy is also permitted, as long as there is at least 3 months’ recovery following the last administration of therapy prior to study entry.
* Radiotherapy during the study or within 3 weeks prior to first dose of study drug. Palliative radiotherapy will be allowed as descr
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable. Subjects should have measurable and evaluable disease (as per the RECIST criteria), and not have received prior cytotoxic chemotherapy.
Classification code 10027481
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Intervention(s)
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Product Name: Sorafenib
Product Code: BAY 43-9006
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sorafenib
CAS Number: Not avail.
Current Sponsor code: BAY 43-9006 tosylate (BAY 54-9085)
Other descriptive name: 4-{4-[3-(4-chloro-3-trifluoromethyl-phenyl)-ureido-phenoxy}-pyridine-2-carboxylic acid methylamide-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Product Name: Dacarbazine
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Dacarbazine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100, 200-plus others
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Primary Outcome(s)
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Main Objective: To evaluate the overall tumour response rate (including complete responses (CR) and partial responses (PR)) of oral BAY 43-9006 given continuously in combination with repeated 21-day cycles of dacarbazine, in subjects with advanced, metastatic melanoma. The response rate will be determined using the RECIST criteria
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Primary end point(s): Overall tumour response rate. This will be calculated by dividing the total number of complete and partial responses seen by the total number of subjects enrolled.
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Secondary Objective: To evaluate:
Progression-free survival;
Overall survival;
Duration of response for those subjects who exhibit an objective response (PR or CR);
Disease control rate (PR+CR+SD);
Duration of stable disease for those subjects who exhibit SD as their best response;
Time to response for those subjects who exhibit an objective response (PR or CR);
Evaluate the safety and toxicity profile of the combination study treatment;
Explore possible BRAF and RAS mutations in melanoma biopsy samples that may correspond with a better response rate to the combination therapy of BAY 43-9006 and dacarbazine;
Analyse pERK and pVEGFR2 levels in melanoma biopsy samples to determine whether increased phosphorylation corresponds with a better response rate to the combination therapy of BAY 43-9006 and dacarbazine, and whether levels are modulated by the combination therapy. Other markers associated with these pathways may also be analysed.
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Secondary ID(s)
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BAY 43-9006/11538
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N/A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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