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Clinical Trials/EUCTR2004-000725-30-GB
EUCTR2004-000725-30-GBActive, not recruitingPhase 1

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

Bayer HealthCare AG0 sites0 target enrollmentStarted: February 23, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

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

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