BI 2536 Second Line Monotherapy in SCLC

NCT00412880 | Completed Phase 2 Results

• 1 other identifier: 1216.11
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

Carcinoma, Small Cell

Outcome Measures

Primary Outcomes (1)

• 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).

  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 (6)

• Progression Free Survival (PFS)

  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

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

• Duration of Overall Response

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

• Occurrence and Intensity of Adverse Events Graded According to CTCAE

  From the start of treatment till the last infusion + 21 days, up to 36 weeks.

• Number of Participants With Dose Limiting Toxicity

  From the start of treatment till the last treatment + 21 days, up to 36 weeks.

Study Arms (1)

BI 2536

EXPERIMENTAL

Total Patients

Drug: BI 2536

Interventions

BI 2536 DRUG

Intravenous Infusion

BI 2536

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

1216.11.007 Boehringer Ingelheim Investigational Site

Fayetteville, Arkansas, United States

Location

1216.11.003 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1216.11.006 Boehringer Ingelheim Investigational Site

Evanston, Illinois, United States

Location

1216.11.002 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1216.11.005 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1216.11.001 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Location

1216.11.011 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1216.11.010 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1216.11.012 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Location

1216.11.009 Alberta Cancer Board

Edmonton, Alberta, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Small Cell

Interventions

BI 2536

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Limitations and Caveats

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

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: February 14, 2007
• Primary Completion: June 30, 2008
• Study Completion: June 30, 2008
• Last Updated: June 22, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Locations

US (9); CA (1)