EUCTR2005-004827-20-GB
Active, not recruiting
Not Applicable
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 enrollmentNovember 11, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Histologically-confirmed advanced solid tumours for which no standard therapy exists or has failed therapy
- Sponsor
- anoCarrier Co., Ltd.
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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