Metastatic malignant melanoma
Conditions
Interventions
Product Name: n. a.
Product Code: MS-275
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not available
Current Sponsor code: MS-275
Other descriptive name: HDAC Inhibitor
Concentration un
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed nonresectable metastatic melanoma Stage III or IV (per American Joint Committee on Cancer/2002 criteria), 2) At least one and no more than two previous systemic therapies for metastatic melanoma (excluding prior systemic therapy given for lymph node metastasis as preoperative neoadjuvant and/or postoperative adjuvant therapy), 3) Presence of at least one lesion fulfilling the minimum RECIST size requirements for a target lesion (>=20 mm with conventional techniques or >=10 mm with spiral CT scan), 4) Able to undergo either contrast-enhanced CT scan or contrast-enhanced MRI scan for tumor assessment. 5) Lack of response to or progression after most recent systemic therapy for metastatic melanoma, 6) Life expectancy greater than 3 months, 7) Age >= 18 years, 8) Adequate organ and bone marrow functions as defined below: -- Absolute neutrophil count (ANC) >=1500/µl, -- Platelets >=100,000/µl, -- Creatinine =60 ml/min x 1.73 m2 BSA, -- Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pregnancy, breast feeding, 2) Diagnosis of uveal melanoma, 3) Known history of HIV infection, 4) ECOG performance status >= 2, 5) Active malignancy in the 5 years prior to enrollment other than non-uveal melanoma, basal cell carcinoma, or cervical carcinoma in situ, 6) Ongoing effects from previous investigational drug studies or concomitant participation in other investigational drug studies 7) Prior use of MS-275 or any other HDAC inhibitor, 8) History of allergic reactions attributed to compounds of similar chemical or biologic composition to MS-275, 9) Known or suspected brain metastases, 10) Anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy, and hormone therapy) delivered within 4 weeks prior to the 1st dose of study drug, and 2 weeks prior for palliative “spot” radiotherapy to bone metastases), 11) Active gastrointestinal conditions (e.g., gastric resection, colitis, or prior intestinal surgery) that might predispose for poor drug absorption, 12) Major surgery (including but not limited to thoracic, abdominal, pelvic, or ophthalmologic surgery, neurosurgery, and large joint surgery such as knee or hip procedures) within 4 weeks prior to enrollment, 13) Concomitant use of corticosteroids (except when administered for refractory nausea/vomiting) or valproic acid, 14) Uncontrolled intercurrent illness—including but not limited to—ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements, 15) Hypophosphatemia < 2.5 mg/dl (0.8 mmol/l) at screening, if not corrected in the screening period 16) Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study 17) Prior enrollment into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 2 different dosing schedules of MS-275 in patients with metastatic melanoma;Secondary Objective: To evaluate the safety of MS-275 in patients with metastatic melanoma To assess the pharmacokinetic profile of MS-275 in patients with metastatic melanoma Optional substudies: To assess the pharmacogenomic effects of MS-275 (participating sites and consenting patients only) To assess the pharmacogenetic basis for response to MS-275 (participating sites and consenting patients only) ;Primary end point(s): Overall tumor response rate defined as the proportion of patients with a best tumor response of PR or CR within the first 6 cycles of treatment. | — |
Countries
Germany
Outcome results
None listed