Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Immune System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Hypersensitivity

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Small Cell Lung Cancer

BI 2536

Boehringer Ingelheim

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

BI 2536 Second Line Monotherapy in SCLC

An Open-label Phase II Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of 200 mg i.v. BI 2536 Administered Every 21 Days in Patients With Sensitive Relapse Small Cell Lung Cancer

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).

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.

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.

The duration of overall objective response (OR) was measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death any cause. OR is defined as either: CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).

Occurrence and intensity of adverse events graded according to common terminology criteria of adverse event (CTCAE) version 3.0.

Number of Participants with Dose Limiting Toxicity. Dose limiting toxicity was defined as:

* drug related CTCAE Grade 3 or greater non-hematological toxicity (excluding untreated nausea, vomiting or diarrhea)
* drug related CTCAE Grade 4 neutropenia for 7 or more days or complicated by infection
* CTCAE Grade 4 thrombocytopenia.

Number of participants with an increase in common terminology criteria (CTC) Grade classification for hematological and clinical chemistry laboratory measures. Changes from Baseline in laboratory measures were classified according to CTC Grades 1-4. Results summarizes the number of patients who had a change in laboratory value that represented an increase in CTC Grade classification during the study (based on maximum Grade).

Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.

Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.

BI 2536 200 mg

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

The criteria for expanding the trial to the second stage were not achieved and the trial was stopped early per trial design.

Boehringer Ingelheim, Call Center

Complete response

Partial response

Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536. Four patients were excluded from this endpoint due to not having completed two treatment cycles (21 days each).

Number of Participants With Objective Tumor Response

Progression Free Survival (PFS)

Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536..

Overall Survival

Analysis of duration of overall response was not conducted, as there were no responders

Spots Global Cancer Trial Database for BI 2536 Second Line Monotherapy in SCLC

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial