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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31433

Enrollment

Registered

2007-10-15

Start date

2008-07-31

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced NSCLC

Interventions

NAMI-A will be administered at day 1, 8 and 15 while Gemcitabine will be administered at day 2, 9 and 16, for a 28-day cycle up to progressive disease or intolerance or patient refusal to continue t

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
to assess the time to disease progression.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)