Phase I Study to Determine the Maximum Tolerated Dose of NC-6004 in Patients with Solid Tumours - Phase I dose-escalation Study of NC-6001 in patients with solid tumours

anoCarrier Co., Ltd.0 sites30 target enrollmentStarted: November 11, 2005Last updated: April 18, 2012

Conditions

Trial Snapshot

No summary available.

•Male and female patients aged = 18 years
•Histologically-confirmed advanced solid tumours for which no standard therapy exists or has failed therapy
•Only one previous course of platinum with maximum doses as follows:
•-Cisplatin 450 mg/m2
•-Oxaliplatin 960 mg /m2
•-Carboplatin 42 mg/ml.min cumulative AUC
•Disease evaluable for response (including tumour markers where applicable). If the only measurable lesion is in a previously irradiated field, clear cut progression after radiation must be documented
•Eastern Cooperative Oncology Group (ECOG) Performance status of = 2
•Life expectancy of at least 12 weeks
•Adequate bone marrow function
•-Absolute neutrophil count (ANC) = 1500 cells/µL
•-Platelets = 100,000 cells/µL
•-Haemoglobin = 9.0g/dL
•Adequate renal function with chromium-51 (51Cr)–EDTA =60 mL/min
•If pre-menopausal, willing to use barrier contraception during study participation (except for patients with bilateral tubal ligation or who have undergone hysterectomy or other sterilisation procedure)
•Written informed consent to participate in the trial
•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

•Known severe hypersensitivity to cisplatin or any of the excipients of this product
•More than one previous course of platinum therapy
•Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to <20% of bone marrow), immunotherapy, or corticosteroids (greater than 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
•Serum bilirubin >1.5 times the upper limit of the reference range (ULRR) in the absence of liver metastases
•Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases
•Serum calcium above the ULRR
•As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
•Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
•Pregnancy or breastfeeding.
•Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
•Evidence of ototoxicity as assessed by audiometry or other neurotoxicity = Grade 2
•Concurrent treatment with other experimental drugs and/or anticancer agents

Sponsor

anoCarrier Co., Ltd.