A Phase I/II Study with NAMI-A a Novel Ruthenium Anticancer Agent, and Gemcitabine Combination Second-Line Therapy in NSCLC Patients

Completed

Conditions: advanced NSCLC
10038666

Registration Number: NL-OMON31433

Lead Sponsor: niversita degli Studi di Trieste

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

Inclusion Criteria:
- age >= 18 years
- documented diagnosis of advanced NSCLC
- presence of metastases (M1 or higher)
- previous treatment with cisplatin or carboplatin
- previous anticancer chemotherapy discontinued for at least 4 weeks before entry into the study
- radiotherapy discontinued for at least 4 weeks
- WHO performance status of 0-2
- Adequate renal function (creatinine £ 120 uM or creatinine clearance > 50 mL/min calculated by Cockcroft Gault formula) and adequate hepatic function (total bilirubin <= 25 mM, AST and ALT less or equal to twice normal upper limit, but in case of liver metastases these values have to be <= 5 times the normal upper limit)
- Life expectancy of at least 16 weeks, necessary to cover 3 courses of treatment and 4 weeks of follow-up
- Written informed consent

Exclusion Criteria

- Breast feeding or pregnancy or inadequate use of contraception- concomitant acute infection or inflammatory disease (e.g. rheumatoid arthritis)- clinical evidence of hearing loss (>=CTC grade 2) - prior treatment with ruthenium complexes- current participation in other clinical trials in oncology

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To establish the optimal dose of the combination for second-line therapy with<br /><br>NAMI-A and Gemcitabine (Phase I part) and<br /><br>to assess the response rate according to RECIST criteria (Phase II part) in<br /><br>advanced NSCLC and<br /><br>to determine the profile of adverse events (both Phase I and Phase II part).</p><br>

Secondary Outcome Measures