A Phase II Trial of Single-Agent Amrubicin in Patients with Extensive Disease Small CellLung Cancer that is Refractory or Progressive within 90 Days of Completion of First-LinePlatinum-based Chemotherapy

Conditions: MedDRA version: 8.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stage
Extensive Disease Small Cell Lung Cancer that is refractory or progressive

Registration Number: EUCTR2006-004785-14-NL

Lead Sponsor: Cabrellis Pharmaceuticals Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

Patients must meet all the following criteria for inclusion into the study at the time of screening.
1. Histological or cytological diagnosis of SCLC
2. Refractory to first-line platinum-based chemotherapy (i.e., has received one prior
platinum-based chemotherapy regimen) defined as one of the following:
a. Best response to first-line chemotherapy is radiographically documented progression
(refractory disease)
b. Best response to first-line chemotherapy is radiographically documented response or
stable disease, with subsequent documented progression during continuing
chemotherapy (resistant relapse)
c. Documented progression within 90 days of completion of first-line chemotherapy
(end of last cycle), regardless of best response to treatment (resistant relapse)
3. At least 18 years of age
4. ECOG Performance Status of 0, 1, or 2
5. Measurable disease defined by RECIST criteria.
a. Measurable disease: The presence of at least one measurable lesion. If only one
lesion is present, the neoplastic nature of the disease site should be confirmed by
histology and/or cytology
b. Measurable lesion: Lesions that can be accurately measured in at least one
dimension with the longest diameter = 20 mm using conventional techniques or =
10 mm using spiral CT scans.
CT (including spiral CT) scans and MRI are the preferred methods of measurement;
however, chest x-rays are acceptable if the lesions are clearly defined and surrounded
by aerated lung. Clinically detected lesions will only be considered measurable when
they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of
skin lesions, documentation by color photography, including a ruler to estimate the
size of the lesion is required.
6. Adequate organ function including the following:
• Adequate bone marrow reserve: absolute neutrophil (segmented and bands)
count (ANC) greater or equal to 1500 cells/µL, platelet count greater or equal to 100,000 cells/µL and hemoglobin greater or equal to 9 g/dL
• Hepatic: bilirubin less than or equal to 1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3.0 X ULN.
• Renal: serum creatinine less than 2.0 mg/dL or calculated creatinine clearance
more than 60 mL/min
• Cardiac: Left ventricular ejection fraction (LVEF) greater or equal to 50% by MUGA or echocardiography (intra-patient reassessment of LVEF should be performed via the same method throughout the study).
7. Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-producing potential, use of effective
contraceptive methods during the study.
8. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

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 will be excluded from the study if any of the following apply:
1. Pregnant or nursing women
2. Radiotherapy within the previous 30 days. Recovery from the acute toxic effects of
radiation required prior to study enrollment. Measurable lesions that have been
previously irradiated must be enlarging to be considered target lesions. Prior radiation
therapy allowed to less than 25% of the bone marrow.
3. Prior anthracycline treatment
4. Participation in any investigational drug study within 28 days prior to study entry
5. Patients with second primary malignancy (except in situ carcinoma of the cervix or
adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated
at least 2 years previously with surgery and or radiotherapy and no evidence of
recurrence since that time).
6. Concurrent severe or uncontrolled medical disease (i.e., active systemic infection,
diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the
opinion of the Investigator, would compromise the safety of the patient or compromise
the ability of the patient to complete the study.
7. Symptomatic central nervous system metastases. Patients with asymptomatic brain
metastases are allowed. The patient must be stable after radiotherapy for 2 weeks or more and off corticosteroids for 1 week or more.
8. History of interstitial lung disease or pulmonary fibrosis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is the objective tumour response rate (RECIST).<br><br>;Secondary Objective: • Duration of overall response<br>• Time to tumor progression (TTP)<br>• Progression free survival (PFS)<br>• Overall survival<br>• Toxicity profile<br>• Incidence of cardiomyopathy<br>• Incidence of CNS progression<br>• Pharmacokinetic parameters<br><br>There are also exploratory objectives:<br>• ORR based on prior response to first-line therapy<br>• Disease control rate (ORR by RECIST plus SD x 12 weeks)<br>• Duration of disease control;Primary end point(s): Objective tumor response rate (RECIST).<br><br>

Secondary Outcome Measures

Name	Time	Method

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