BI 2536 Second Line Monotherapy in SCLC

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-14

Study Completion Date

2008-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Carcinoma, Small Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 2536

Total Patients

Group Type EXPERIMENTAL

BI 2536

Intervention Type DRUG

Intravenous Infusion

Interventions

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BI 2536

Intravenous Infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No