A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a 21-Day Cycle as Third-line Treatment in Patients With Unresectable, Metastatic Non-Small Cell Lung Cancer - JZAC

• Conditions: nresectable, metastatic non-small cell lung cancer (NSCLC); MedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic

• Registration Number: EUCTR2006-002321-23-DE
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-19
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who:
[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) =1.5 x 109/L prior to treatment, platelets =100 x 109/L, and hemoglobin =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 = 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

Patients who:
[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 = 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified