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
- Conditions
- Histologically-confirmed advanced solid tumours for which no standard therapy exists or has failed therapy
- Registration Number
- EUCTR2005-004827-20-GB
- Lead Sponsor
- anoCarrier Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method