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

• Register: EUCTR
• Last refreshed on: 28 January 2013
• Main ID: EUCTR2006-002321-23-DE
• Date of registration: 19/05/2006
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company Limited
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 29/08/2006
• Target sample size: 60
• 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: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany, Italy

Key inclusion & exclusion criteria

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.


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

Health Condition(s) or Problem(s) studied

Unresectable, metastatic non-small cell lung cancer (NSCLC)
MedDRA version: 9.1 Level: LLT Classification code 10059515 Term: Non-small cell lung cancer metastatic

Intervention(s)

Product Name: LY573636
Product Code: LY573636
Pharmaceutical Form: Powder for solution 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): To estimate time-to-progressive disease and 90% confidence limits for this patient population.

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: To estimate the 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)

H8K-MC-JZAC (a)