BI 2536 Second Line Monotherapy in SCLC

Boehringer Ingelheim23 enrolled

Overview

Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Small Cell

Interventions

BI 2536DRUG

Intravenous Infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy. * Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater. * Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines. Exclusion Criteria: * More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology. * Symptomatic brain metastases or leptomeningeal disease * Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer) * Absolute neutrophil count (ANC) \<1,500/µl, platelet count \<100,000/µl, or hemoglobin \<9 mg/dl * Total bilirubin \>1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) \>2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \>5 x ULN in case of known liver metastases, serum creatinine \>2.0 mg/dl (\>176 µmol/L, SI Unit equivalent) * Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug * Radiation therapy within the past 2 weeks prior to or during treatment with the trial drug * Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection * Known or suspected active drug or alcohol abuse * Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug * Patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (Coumadin ®) * Patients with neuropathy (sensory or motor) CTCAE 3

Locations (10)

1216.11.007 Boehringer Ingelheim Investigational Site

Fayetteville, Arkansas, United States

1216.11.003 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

1216.11.006 Boehringer Ingelheim Investigational Site

Evanston, Illinois, United States

Outcomes

Primary Outcomes

Number of Participants With Objective Tumor Response

Objective tumor response by investigator was assessed for patients who completed at least two courses of BI 2536 treatment. Tumor images from CT (computed tomography) scan and MRI (magnetic resonance imaging) were evaluated using Response evaluation criteria in solid tumors (RECIST) criteria to determine best tumor response. Objective response (OR) was defined as either: complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).

Time frame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.

Secondary Outcomes

Progression Free Survival (PFS)

Progression free survival (PFS) was defined as the duration of time from start of treatment to time of progression (or death any cause). Patients who did not experience progression or death during the trial were censored at the date of last tumor assessment visit at which the patient was evaluated and did not experience progressive disease. Patients who dropped out before any evaluation of response, radiological, clinical, or pathological, were censored at the start of treatment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Time frame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.

Overall Survival

Overall survival (OS) was reported as number of participants with event. Overall survival is the time from first treatment to death. In case there was no occurrence of death or progression during follow-up, the time was censored. Median survival time was not calculated due to the low number of deaths in the trial.

Time frame: From the start of treatment till death or discontinuation, up to 36 weeks.

Data from ClinicalTrials.gov

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