A Phase 2 Study of LY573636 Administered a san Intravenous Infusion on Day 1 of a 21-Day cycle as third-line Treatment in patients with unresectable, metastatic non-Small Cell lung cancer - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002321-23-IT
• Date of registration: 06/10/2006
• Prospective Registration: No
• Primary sponsor: ELI LILLY
• Public title: A Phase 2 Study of LY573636 Administered a san Intravenous Infusion on Day 1 of a 21-Day cycle as third-line Treatment in patients with unresectable, metastatic non-Small Cell lung cancer - ND
• Scientific title: A Phase 2 Study of LY573636 Administered a san Intravenous Infusion on Day 1 of a 21-Day cycle as third-line Treatment in patients with unresectable, metastatic non-Small Cell lung cancer - ND
• Date of first enrolment: 06/09/2006
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002321-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1 Have a histologic and/or cytologic diagnosis of metastatic NSCLC that is unresectable. Patients with unresectable, Stage IIIB disease are also eligible. 2 Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors RECIST . 3 Are at least 18 years of age. 4 Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group ECOG Scale 5 Have received two previous systemic treatment regimens for metastatic NSCLC, one of which must have been platinum-based. 6 Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days 6 weeks for mitomycin-C or nitrosoureas before study enrollment and recovered from the acute effects of therapy except alopecia . 7 Have adequate organ function including Bone Marrow Reserve Absolute neutrophil count ANC 8805;1.5 x 109/L prior to treatment, platelets 8805;100 x 109/L, and hemoglobin 8805;8 g/dL transfusions are not allowed to reach 8 g/dL prior to enrollment . Hepatic Bilirubin 1.5 times the upper limit of normal ULN . Alkaline phosphatase and transaminases ALT and AST 5 times ULN Renal Serum creatinine at or below the ULN. No known active renal disease 8 Have a serum albumin level 8805; 30 g/L or 3.0 g/dL. 9 Males and females with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug. 10 Exhibit patient compliance and geographic proximity that allow for adequate follow-up. 11 Have given written informed consent approved by Lilly and the ethical review board ERB governing the site.
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

Exclusion criteria:
12 Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. 13 Have received 8805; 3 previous systemic treatment regimens for metastatic NSCLC. 14 Patients with documented central nervous system or leptomeningeal metastasis brain metastasis at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. 15 Patients with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study at the discretion of the investigator . 16 Patients with a second primary malignancy that could affect compliance with the protocol or interpretation of the results. NOTE Patients with adequately treated carcinoma of the skin excluding melanoma and patients with a prior history of malignancy who have been disease-free for more than 2 years are eligible. 17 Patients with serious preexisting medical conditions at the investigator s discretion . 18 Patients actively receiving warfarin Coumadin therapy for treatment of venous thrombosis or other prothrombotic conditions. NOTE Patients receiving low dose 1 mg daily warfarin will be allowed in this study. For those patients, more frequent monitoring of PT INR /aPTT will be required. 19 Persons who have previously completed or withdrawn from this study or any other study investigating LY573636. 20 Women who are pregnant or lactating.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients affected by non small cell lung cancer who had already received 2 regimens of chemotherapy for the treatment of metastatic disease
MedDRA version: 8.1 Level: LLT Classification code 10059515 Term: Non-small cell lung cancer metastatic

Intervention(s)

Product Name: LY573636
Pharmaceutical Form: Powder for infusion*
CAS Number: 519055-63-1
Current Sponsor code: LY573636
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Primary Outcome(s)

Primary end point(s): The primary objective of this study is to estimate time-to-progressive disease for patients who have received LY573636 after two prior treatment regimens of systemic therapy for unresectable, metastatic non-small cell lung cancer NSCLC .

Secondary Objective: to characterize the progression-free survival distribution to estimate the objective response rate complete response CR and partial response PR and clinical response rate CR PR stable disease to evaluate the pharmacokinetics of LY573636 using a limited sampling methodology in this population to estimate time-to-event variables, such as overall survival time, duration of overall objective response up to 1 year , and duration of stable disease up to 1 year to evaluate the safety of LY573636 in this patient population.

Main Objective: The primary objective of this study is to estimate time-to-progressive disease for patients who have received LY573636 after two prior treatment regimens of systemic therapy for unresectable, metastatic non-small cell lung cancer NSCLC .

Secondary ID(s)

2006-002321-23-DE

H8K-MC-JZAC