BIBF 1120 as Second Line Treatment for Small Cell Lung Cancer

NCT01441297 | Completed Phase 2

• 1 other identifier: NCCCTS-10-525
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Although chemotherapy is the primary treatment option for small cell lung cancer (SCLC), longterm survival is rare. SCLC is initially chemosensitive, but rapidly relapses in a chemoresistant form with an overall survival of \<5%. Consequently, novel therapies are urgently required and will likely arise from an improved understanding of the disease biology. Some preclinical studies have showed that fibroblast growth factor-2 induces proliferation and

Conditions

Small Cell Lung Cancer; Small Cell Lung Cancer Recurrent

Keywords

recurrent small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  To assess the efficacy of BIBF1120 as second-line treatment in patients with recurrent small cell lung caner

  every 8 weeks

Secondary Outcomes (3)

• Overall survival rate

  every 8 weeks

• Progression free survival

  every 8 weeks

• Toxicity

  every 4 weeks

Study Arms (1)

study arm

EXPERIMENTAL

BIBF 1120 study arm

Drug: BIBF 1120

Interventions

BIBF 1120 DRUG

BIBF 1120 200mg bid, PO, daily until PD

study arm

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed SCLC
• Progression during or after prior first line chemotherapy.
• At least one target tumor lesion RECIST 1.1)
• Life expectancy of at least three months
• ECOG PS 0-2
• Written informed consent

You may not qualify if:

• Previous therapy with other VGFR inhibitors (other than bevacizumab)
• Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy
• Chemo-, hormone-, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for brain and extremities) within the past 3 weeks prior to treatment with the trial drug i.e., the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be 3 weeks
• Treatment with other investigational drugs or treatment in another clinical trial within the past three weeks before start of therapy or concomitantly with this trial
• Concomitant yellow fever vaccination
• Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic off steroids
• Radiographic evidence of cavitary or necrotic tumors
• Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
• History of clinically significant haemoptysis within the past 3 months (more than one teaspoon of fresh blood per day)
• Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid ≤325mg per day)
• History of major thrombotic or clinically relevant major bleeding event in the past 6 months
• Known inherited predisposition to bleeding or thrombosis
• Significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 12 months, congestive heart failure \> NYHA II, serious cardiac arrhythmia, pericardial effusion)
• Calculated creatinine clearance by Cockcroft Gault \<45ml/min
• Proteinuria CTCAE grade 2 or greater

Sponsors & Collaborators

• Ji-youn Han: lead
• National Cancer Center, Korea: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (1)

• Han JY, Kim HY, Lim KY, Hwangbo B, Lee JS. A phase II study of nintedanib in patients with relapsed small cell lung cancer. Lung Cancer. 2016 Jun;96:108-12. doi: 10.1016/j.lungcan.2016.04.002. Epub 2016 Apr 6.

  PMID: 27133759 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ji-Youn Han, PhD.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Center for Lung Cancer

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 27, 2011
• Study Start: December 1, 2011
• Primary Completion: October 31, 2015
• Study Completion: March 31, 2016
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

KR (1)